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  1. 1. Provide a clear description of your needs and your expectations of an expert, consultant or job candidate and Zintro will match it with the most relevant professionals in our platform.
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Recent External Audit Inquiries

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New Jersey Pharmaceutical Compliance

Compliance specialist - bergen county nj essential job function: responsible for interacting with customers on quality issues. Responsible for the receipt of all notices of investigations and logging them into the investigations spreadsheet. Responsible for the receipt of independent capas and logging them into the capa spreadsheet. Responsible for reviewing investigation reports for accuracy, compliance and completion. Responsible for performing internal and external audits and completing the pertinent audit agenda and reports. Requirements- • pharmaceutical background • excellent documentation • bachelor's degree, in science field desired • 3-5 years investigation experience • 5+ years in qa role in pharma industry • at least 2 years of auditing experience • 3-5 years working in a department responsible for assigning and assessing the effectiveness of capa’s • solid oral dosage experience, would also consider a candidate with experience in liquids, semi-solid, capsules, injectables (if candidate possesses all other qualifications!) general information: experience in the pharmaceutical industry. Bachelor’s degree in science field desired. Job responsibilities include but not limited to: • investigate deviations and initiate the appropriate corrective and/or preventive actions to prevent re-occurrence of the incident. • perform root cause analysis. • perform product impact assessment of deviations. • provide qa support during the investigation process. • perform tracking and trending of deviations and capas. • prepare deviation and capa metrics on a monthly basis. • provide support during fda inspections. • responsible for the receipt all notices of investigations and logging them into the investigations spreadsheet.

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    Ramy |validation supervisor

    hi, i would like to apply for the job if you are interested please contact me, regards...

    15 Minutes Later
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    Timothy |Principal

    I am former FDA and as a consultant for 18 + years I have furnished clients with quality system audi...

    1.3 Hours Later
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    Sivaraman |Director

    I have 22 years experience in quality control and quality compliance. Right now,i head up a big team...

    8.3 Hours Later
+4 Other Responses
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Environmental Compliance Audit

I am looing for an expert in the field of environmental compliance audits for gas and oil companies. My client is in west africa, and is looking to set up their own internal environmental compliance audit program.

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    Fidelis |CEO

    I will be glad to offer my services in audit and environmental compliance. Let's ***** ASAP. Add me....

    1.6 Hours Later
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    Dale |Principal

    I would be happy to discuss setting up an internal compliance audit program. There are several thin...

    3.4 Hours Later
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    Anita |President, EHS Consultant

    Our small firm has experts in Environmental Compliance Auditing and we have audited oil and gas loca...

    4.3 Hours Later
+13 Other Responses
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Quality Assurance Development In California

This is a sr. Director of quality assurance,development full time position opportunity in california. Overview: this position will have oversight and leadership of developmental quality assurance programs to meet phase appropriate compliance, validation, and gxp quality assurance requirements. Responsibilities: -establish and maintain a robust quality program that will effectively support the various phases of drug development – preclinical through phase 3, plus product/process improvements. -employ the principles of ich q8 (pharmaceutical development) and q9 (risk management) to the development of manufacturing processes. -ensure a systematic approach to development is employed that begins with pre-defined objectives and emphasizes product and process understanding and process control based on sound science and quality risk management. -provide leadership and managerial oversight to the quality department responsible for development qa. -establish and maintain a phase appropriate approach to product/process development qa. -as project team member, represent qa on product development teams including pre-clinical, phase 1, 2, and 3 development studies, and manufacturing improvement teams. -responsible for document review and qa release of ds/dp to be used in phase 1, 2, and 3 clinical studies. -responsible for phase appropriate quality systems implementation for ds/dp manufactured for use in phase 1, 2, and 3 clinical studies. -acts as technical advisor to vp global quality on topics related to development and commercial quality. -develop and implement effective development qa programs aligned with corporate strategic initiatives and business goals. -interpret regulatory authority regulations, guidelines and policies. Utilize internal audits and quality compliance assessments programs to evaluate processes and procedures as they pertain to product development activities. -must be able to maintain a “big picture” perspective without losing site of the details necessary to meet deliverables and deadlines. -supervise and develop quality personnel. -direct the review and approval of the applicable sops, batch records, test methods, raw material specifications. -provide quality expertise as needed for deviations reports and out-of-specification reports. -ensure that manufacturing processes, equipment, facilities meet phase appropriate gmp requirements. -ensure that suppliers and contract manufacturers associated with product/process development are operating in compliance with state, federal, and international gxp regulations and guidelines as necessary through an external audit program. -hire and/or develop the team to establish and maintain efficient and effective quality systems and programs as they relate to product/process development. -develop operational budgets, cost controls, cost estimates, capacity and resource plans to support corporate strategic business objectives. Qualifications: -ba/bs in a relevant scientific discipline and a minimum of 15 years industry experience with 7+ years of management experience providing both strategic and leadership guidance to an organization in quality assurance. For senior director level consideration, the ideal candidate must have at least 2 years’ experience at the director level. -must have a development quality background from the biotechnology/pharmaceutical industry. -experience in quality management and compliance systems. -in-depth knowledge development qa and experience implementing phase appropriate quality systems to achieve gxp compliance. Contact us here on zintro for further details.

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    Frederick |President

    Thank you for the opportunity- but this is way outside my area of expertise. Best wishes and good l...

    12.4 Hours Later
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    Monica |QA Specialist

    I`m interested in the proposal, please let me know where I can send you my resume. I have to say tha...

    20.9 Hours Later
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    Michael |CMSO , Chief Medical Strategies Officer

    Thanks...but i live in NY.....great opportunity!...

    1.7 Days Later
+13 Other Responses
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Healthcare Compliance

I am looking for a compliance consulting firm in chicago. I want a small firm (less than 10) with at least 5 years of physical therapy consulting experience. I am looking for someone who can review compliance manuals and also perform annual facility audits.

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    Abhijit |Project Manager

    Hi, I am experienced in this field and currently work as a Project manager in healthcare compliance ...

    20 Hours Later
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    Charity |Pharmaceutical, Biotechnology and Medica

    Sorry that I cannot be of help to you with regards to this request. Thanks...

    79 Days Later
+2 Other Responses
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Sarbanes-oxley Compliance

· industry criteria: consumer goods · domain: sarbanes oxley act knowledge · function: finance & accounting · geographic focus: us · previous experience/ past organizations worked with: mondelez, unilever, nestle, kellogg’s · years of experience: 10+ · key specialization: sox, icfr, global implementation, sox designing, sox optimization · key responsibilities: what are the factors every company going through large transformations around managing sox compliance bear in mind how call can technology help in building a centre of excellence which shall provide visibility to the corporate and in country management how does stat auditor respond to the setting up in terms of relying on work done by others? Which all areas can sox controls be optimized more than not how can one integrate the sox with other internal control programs · duration of engagement: 12 weeks

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    Jay |Principal

    Assisting ***** *****anies with compliance with SOX since 2003. Represented to ...

    40 Minutes Later
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    Sokol |President

    Good afternoon, and thank you for your inquiry below. I'm a Sarbanes-Oxley Subject *****rt (S...

    47 Minutes Later
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    Garth |Zintro Expert

    GARTH ERICKSON, CPA, PC Phone: 949 ***** Email: *****- SUMMARY OF EXPERIENCE • Certi...

    1.3 Hours Later
+9 Other Responses
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Quality Management System

Our client has a quality assurance & regulatory compliance manager position in mahwah, new jersey description: the manager, quality assurance & regulatory compliance will ensure overall quality management system (qms) compliance with applicable regulatory and statutory requirements. The successful candidate will manage the manufacturing site’s internal and external audit functions and will coordinate activities of third party audits /visits. In addition, the manager, quality assurance & regulatory compliance will be responsible for leading and managing a group of quality professionals to ensure a high level of quality management system and regulatory compliance in the plant. This position will be responsible for quality management system improvement, procedure development, and qms implementation. The manager will coordinate management review, capa, ncrb, complaints, product field actions, and related document control functions. Detailed responsibilities of the manager, quality assurance & regulatory compliance include, but are not limited to the following: *ensure overall qms system compliance with applicable regulatory and statutory requirements. *perform internal quality assurance audits to 21cfr 820, iso 9001:2000, iso 13485:2003, 93/42/eec and other applicable standards to ensure corporate and regulatory compliance *develop and conduct effective training programs on related qa topics. *conduct and support benchmarking activities. *identify areas of opportunity and support continual improvement of the quality management system identify, develop, and report qms metrics. *manage internal audits, capa system, complaint handling (investigation/resolution), document control. Requirements: a bachelor's degree in a scientific or other relevant field is required. A master's degree or equivalent additional coursework is desirable. Internal or lead auditor certification (cqa) is preferred. A minimum of 5 years of experience managing a team is also required. 3 years of experience in a quality role in the medical device industry is also desired. Ideal candidates should also possess the following skills/experiences: applied understanding of cgmps, iso 9001, iso 13485, and fda qsr. *demonstrated ability to effectively lead cross-functional/cross-plant project teams using relevant project management tools such as ms project. *demonstrated experience developing quality management systems, designing and developing training programs/courses. Experience with lean and six sigma methodology and tools. *demonstrated auditing experience in medical device or other regulated manufacturing environment (biotech, pharma, military, aerospace, automotive).

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    Mark |President

    Please consider AlvaMed if your client requires contract support in the short-term before they are a...

    1.4 Days Later
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    Erik |Manager

    This sounds interesting. It's a pitty that I can't meet up in person for a chat, since I am seeking ...

    2 Days Later
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    Andrea |Principal Consultant

    Hello, I have 18 years of experience in medical device Quality Systems and *****irs. Wou...

    3.5 Days Later
+5 Other Responses
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Internal Audit And Compliance Software

We are looking to speak with paid customers/users of internal audit and compliance software. We want to have a better understanding of your use case, purchasing considerations and evaluation of other vendors in this space.This would be for a 1-hour paid phone consult. Please respond with a few short statements to the questions below.1. Were you the person personally responsible for evaluating, selecting and implementing internal audit and compliance software in your organization? Please comment on the extent of your involvement in the decision-making process.2. Are you able to speak on the platform's features and functionality? Please comment on your use case.3. Did you also evaluate other competitors? Are you also familiar with soxhub or auditboard?

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    Daniel |Senior Manager Internal Audit

    I'm available, what time works for you/your client? How would the payment get made?...

    2.1 Hours Later
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    Polina |Oversight & Monitoring Lead, Health Care

    Yes I currently support enterprise compliance ***** can address your questions ...

    2.2 Hours Later
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    Sharon |Principal Consultant

    Please feel to contact me I would more than happy to assist you . Sincerely, Sharon Miles *****...

    4.6 Hours Later
+47 Other Responses
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Hipaa Compliance Audit

Hipaa compliance audit for medical management company . .

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    Cynthia |Senior Associate

    Hello, My area of ***** in HIPAA and HITECH compliance as well as other areas of govern...

    39 Minutes Later
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    Adriana |National Director

    Credentialed Health *****gement ***** well as Certified in Healthcare Privacy....

    1 Hour Later
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    Bianca |ERISA Compliance Consultant

    I have gotten a message from you requesting assistance, but I am not sure what the specific issue is...

    1.3 Hours Later
+12 Other Responses
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Accounting & Audit

Brief description: looking out for a very senior accounting professional (e.G. A retired big 4 firm partner) who would have a minimum 5 years of big 4 experience in the capacity of signing partner (i.E. External auditor). He / she should have been responsible for audit of global conglomerates (revenues of ~ usd 15-20 billion) with operations spread across the globe (likes of global cpgr, pharma, automobiles cos., etc. Where audit involves review of multiple locations across the globe) · company: ernst & young, pwc, kpmg, deloitte · function: audit, assurance, sox compliance · domain: finance and accounting · past associations: minimum 5 years of big 4 experience in the capacity of signing partner responsible for audit of global conglomerates with geographic spread likes of uniliver, p&g, walmart, etc. · years of experience: 20+ years, minimum 5 years in capacity as audit signing partner of a big 4 firm · duration of the project: 5 hours · screening question: · have you been the audit signing partner of any global conglomerate?, for how long and what was the size of the co.? · how did you derive the sox scoping / risk assessment? · · what are your views on grading of high / medium / low and % threshold one should consider for risk assessment? · what are your views on % coverage (not materiality threshold) i.E. What should be an acceptable coverage for testing of in-scope b/s and p&l accounts for a global business having presence in 70-80 countries · what is your view on location coverage · · when did you place reliance on your client's management testing and what level of reliance was placed?

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    New |

    Hi, this is an intéressons job. But I would like to know the ***** the package you offer...

    27.7 Days Later
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    Ioana |Business Analyst

    Hello I am an independent consultant with over 6 years of consulting and auditing experience includi...

    27.8 Days Later
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    New |

    Jon Miller II Chesapeake, VA ***** • (757) ***** • ***** ...

    56.9 Days Later
+5 Other Responses
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Commercial Quality Assurance In California

This is a full time opportunity in california: sr. Director, quality assurance - commercial overview: this position will have oversight and leadership of the commercial quality and quality systems teams and be responsible to meet compliance and quality assurance requirements for commercial pharmaceutical manufacturing. Responsibilities: -effectively employ the principles of ich q9 (risk management) and ich q10 (pharmaceutical quality system) -develop and lead a risk based quality management system. -build and maintain robust quality program that will effectively support commercial manufacturing. -provide leadership and managerial oversight to the quality departments responsible for quality systems and commercial quality. -administer commercial quality systems including: -deviation -capa -change control -vendor management -training -internal/external audits -document control -quality management review -annual product review -product/customer complaints quality oversight of contract manufacturing organizations including: -auditing -deviation/change control -batch record review -batch release provide support as necessary to the vp global quality regarding gmp readiness, quality related projects and issues/concerns on a global basis. -conduct ongoing evaluations of quality programs, systems and initiatives to assure that product quality standards and regulatory compliance are achieved. -interpret regulatory authority regulations, guidelines and policies. Utilize internal audits and quality compliance assessments programs to evaluate dynavax processes and procedures. -conduct regular risk assessments to ensure processes and procedures are in compliance with cgmps. -supervise and develop quality personnel including the heads of applicable functional teams. Appropriately resource regulatory inspections. -direct the review and approval of the quality manual, quality policies, protocols, sops, batch records, test methods, raw material specifications, and annual product reviews. -provide quality expertise as needed for deviations reports and out-of-specification reports. -ensure that manufacturing processes, equipment, facilities and systems are validated and that a robust change control system and procedures are developed and maintained to meet state, federal, and international requirements. -ensure that suppliers and contract manufacturers are operating in compliance with state, federal, and international gxp regulations and guidelines through an external audit program. -hire and/or develop the team to establish and maintain efficient and effective quality systems and programs. -develop operational budgets, cost controls, cost estimates, capacity and resource plans as well as facility requirements to support corporate strategic business objectives.. qualifications: -ba/bs in a relevant scientific discipline and a minimum of 15 years industry experience with 7+ years of management experience providing both strategic and leadership guidance to an organization in quality assurance. For senior director level consideration, must have at least 2 years’ experience at the director level. -must have a quality background from the biotechnology/pharmaceutical industry with gmp experience and a successful track record in quality within fda and/or emea regulated environment. -experience in quality management and compliance systems. -in-depth knowledge of qa document control, gxp compliance, and qa auditing. -experience in development qa associated with pre-clinical development and commercial products. --a background in the development of analytical methods preferred. -must have a successful track record in managing fda/eu inspections. Contact us here on zintro for further details.

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    Stefan |Senior Researcher

    I am more than interested of your job offer and despite the fact of being of the age of more than 60...

    4.9 Hours Later
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    Arun Kumar |Associate

    I am keen to explore the said opportunity. Please provide your e-mail address so that I can provide ...

    5.9 Hours Later
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    EMMANUEL |Managing Partner - Independent Contracto

    Kunda Emmanuel Kalaba Address: 1 Tanamerah Kechil Road Singapore – Postal Code ***** Email: kunda....

    5.6 Days Later
+11 Other Responses
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Internal Audit And Compliance Software

We are looking to speak with paid customers/users of internal audit and compliance software. We want to have a better understanding of your use case, purchasing considerations and evaluation of other vendors in this space.This would be for a 1-hour paid phone consult. Please respond with a few short statements to the questions below.1. Were you the person personally responsible for evaluating, selecting and implementing internal audit and compliance software in your organization? Please comment on the extent of your involvement in the decision-making process.2. Are you able to speak on the platform's features and functionality? Please comment on your use case.3. Did you also evaluate other competitors? Are you also familiar with soxhub or auditboard?

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    Daniel |Senior Manager Internal Audit

    I'm available, what time works for you/your client? How would the payment get made?...

    2.1 Hours Later
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    Polina |Oversight & Monitoring Lead, Health Care

    Yes I currently support enterprise compliance ***** can address your questions ...

    2.2 Hours Later
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    Sharon |Principal Consultant

    Please feel to contact me I would more than happy to assist you . Sincerely, Sharon Miles *****...

    4.6 Hours Later
+47 Other Responses
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Oil And Gas Compliance

We are looking for an independent consultant having more than 15 years of experience in dealing with oil and gas contracts and who can help us in an oil and gas contract compliance audit for one of our clients in malaysia. Interested industry experts may reach out to us via zintro.

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    Lyn |Consultant

    I have over 40 years experience at senior level in the Oil and Gas Industry with both end user and v...

    56 Minutes Later
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    Marcel |Managing Partner

    MSi-Support has over 20 years of experience. On request we will send you the CV of our Contract Lawy...

    1.4 Hours Later
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    Gary |Founder Owner

    33 years of global oil and gas commercial and engineering Experience 10 years oil and gas Co 23 yea...

    2.9 Hours Later
+19 Other Responses
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