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Recent Gmp Training Inquiries

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Senior It Gmp Systems

Senior gmp systems analyst: this is a full-time employment opportunity onsite in seattle washington, usa. ***job summary***: designs, implements, and maintains in-house gmp information systems and network software architectures to support gmp processes that meet all customer, business and regulatory requirements through the following activities: - people focus - gmp focus - operational reliability focus - operational efficiency focus ***primary duties and responsibilities of the position***: - provides strategic direction for gmp it operations - defines gmp it standards for services, systems, hardware, and security - develops, manages, implements gmp it improvement projects - develops and maintains standards for procedures and maintenance plans - gmp systems support: implementation, maintenance, documentation, problem resolution & rca - operations support: gmp process and operational support - hardware life cycle management - promoting a safe work environment - attainment indicators: - it gmp compliance - restore lost function - standardization of processes - project support rft - safe working environment - other duties as assigned. ***education requirements***: - bs in it/is or related field / equivalent experience. ***experience and critical skill requirements***: - 3-5 years computer related support and systems administration experience in design, implementation, and maintenance troubleshooting hardware, operating system, and network issues. - 5-7 years it validation or qa it experience, including: support and troubleshooting scientific instruments such as cedex, nova, and akta, technical writing of system documentation and configuration management, systems monitoring and auditing, computerized system validation, disaster recovery and business continuity planning. - proven expertise in project management – planning/organization/execution of it systems lifecycle management – from rfp to retirement. - performs varying complex duties with little/no direct supervision. Can work on long-term issues & projects where little/no instructions or guidelines exist. Able to multi-task on several projects while maintaining daily activities. Ability to manage projects and achieve desired results within specified deadlines, and revising the work plan for complex problems being resolved by cross functional teams. - working knowledge and practical experience of computer and application integration / validation (preferably using gamp methodology), cgmps, and 21 cfr part 11 in an fda regulated environment - knowledge of software testing (fat / sat) and commissioning procedures - ability / experience in managing cross functional it / process automation projects - ability to work hours necessary to support production and /or maintenance activities across multiple sites. - ability to lift up to 40 lbs. With assistance. - ability to work in confined spaces and near operating equipment. - ability to work in loud noise environments ***management responsibilities***: - mentorship responsibility for it staff as well as peers. - responsible for indirect oversight of project team staff when assigned as project team leader. ***competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. ***kindly provide a brief summary of your relevant experience and attach your latest cv along with your response. This full-time employment opportunity does not provide visa sponsorship.

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    New |

    Hi, I am interested...

    4 Days Later
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    Ritu |

    Hi, I am interested...

    23.7 Days Later
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    New |

    1...

    34.9 Days Later
+10 Other Responses
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Gmp Facility Design And Constrcution, Validation.

I am looking for validation experts with strong gmp experience and the dutch language skills. This is an excellent opportunity with a large client in netherlands. This person needs to have experience of validating equipment. This is a permanent position to start asap.

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    Paramdeep |Freelance Consultant

    Hi Michelle, I can handle this Job as i have experience in Manufacturing and know consulting both at...

    10.6 Hours Later
+2 Other Responses
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Gmp Facility Design And Construction, Validation.

Looking to design a gmp facility, implement a quality assurance plan, and develop policy and procedures.

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    RAJENDRA |senior consultant

    we are capable of doing all above mentioned items: GMP, Design, ***** plan etc. Pl do wr...

    1.1 Hours Later
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    Sean |President / Validation and compliance sp

    Hello. My name is Sean D. Benedik and I would be the ideal ***** assist your firm in developi...

    1.2 Hours Later
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    Todd |President, BioAdept

    I am the CEO of biosciences consulting firm. Our team of consultants have the expertise you need. ...

    1.4 Hours Later
+16 Other Responses
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Gmp Publications

Looking for cfr title 21 food & drugs revised as of april 1, 2013

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    suzanne |Member

    You can find this on the FDA website : http://*****pts/cdrh/cfdocs/cfcfr/cfrse...

    1.3 Hours Later
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    Jessica |VP Business Development

    Hello, We received your inquiry and would like to know more about the work you are seeking. Please...

    23.8 Hours Later
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    Gary |President

    I have 30+ years in the pharmaceutical industry, with extensive GMP experience directing GMP-regulat...

    1.3 Days Later
+4 Other Responses
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Pharmaceutical Gmp

We are generic pharmaceutical company located in eastern europe and we are looking for experts on pharmaceutical gmp inspections, regulations and certificates as well as drug registration and file maintenance in russia, kazakhstan and azerbaijan. We need to make quick decision about organization of inspections and strategy that will minimize risk for product supply on cis markets. Expecting your prompt reply. Thanks

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    Lola |Vice Presidentt and Strategic Developmen

    Dear Sir/Madam My consulting company Delta Pharma ***** Saint-Petersburg can help you with your...

    4.5 Hours Later
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    Elena |Consultant

    I can help you with GMP ***** inspection in Russia...

    4.7 Hours Later
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    Konstantin |General Manager

    "Regapharm" is an advisory company. We shall help you in registering medicinal products and pharmace...

    4.7 Hours Later
+13 Other Responses
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Gmp Documentation

Gmp and qms, ich q10,documentation remediation experts 500 sops and 30 policies to align.

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    Roger |CEO and Executive Consultant

    Good morning: You mention that you have 500 SOPs and 30 policies to align with GMP (QMS, ICH Q10 et...

    13 Minutes Later
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    semih |Quality and HSE Manager

    What is the main area of interest?...

    14 Minutes Later
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    Scott |Consultants

    We have helped several clients including multi-billion dollar *****ss their current doc...

    33 Minutes Later
+23 Other Responses
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Medicine Gmp Auditing

Looking for a eu gmp auditor with experience in aseptic and oral solid dosage area design reviews . Engineering experience is essential. Pls contact for further information.

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    Melanie |President/ CEO

    *****...

    1.9 Hours Later
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    Prashant |VP

    Me and my colleague can take up this assignment. Combined we have exposure you requested. with best ...

    4.2 Hours Later
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    Balkrishna |Zintro Expert

    I am interested in this project.I am lead auditor in ISO 9001.I do audits on behalf of third party ...

    4.7 Hours Later
+14 Other Responses
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Gmp Facility Design And Construction

We are a medical device manufacturer of an oral product. We are building a new iso13485 facility which will follow the principles of gmp. We require expert input into the design and qualification of the facility.

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    Samir |Facilities Manager

    Hi, At first glance the assigment looks ineteresting. Could you please provide more *****...

    2.5 Hours Later
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    Vanessa |QA/RA Professional

    I took part of the ***** a new GMP facility (from construction to the delivery of the facili...

    2.5 Hours Later
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    Jonathan |Principal

    We at Reliant FDA Experts are experts in cGMP facility design and ********** devic...

    2.5 Hours Later
+24 Other Responses
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Pharmaceutical Gmp

Expert in pharmaceutical industry gmp and regulatory compliance.

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    Emma |Partner

    We have decades of practical and hands-on experience in the GMP arena and numerous clients who can t...

    1.5 Hours Later
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    Mark |Founding Partner

    What type of pharmaceutical product are you intending to manufacture? (oral, IV, topical, ... bio...

    1.5 Hours Later
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    Karen |Project Management Professional

    I may be interested in this project but need to know more first. Can you provide details about this...

    5.2 Hours Later
+16 Other Responses
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Gmp

We are looking for a person experienced with qa gmp audits to help us audit gmp peptide manufacturing facilities.

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    Gerald |Senior Research Chemist

    I have a lot of experience with GMP. What ***** involved with the analysis? Do you ha...

    1.4 Hours Later
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    Winnie |R&D Manager, QA Manager, Technical Sales

    Dear Sir and/or Madam, I have a food science master degree and over 18 years of GMP and audit experi...

    3.4 Hours Later
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    Gary |President

    I have extensive experience directing GMP studies, performing GMP facility and study audits, manufac...

    4.5 Hours Later
+20 Other Responses
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