Quality Management System
Our client has a quality assurance & regulatory compliance manager position in mahwah, new jersey
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
*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
identify, develop, and report qms metrics.
*manage internal audits, capa system, complaint handling (investigation/resolution),
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).+5 Other Responses
Fda Quality Metrics
i'm a conference producer based in mumbai. I'm working on the 3rd annual data integrity, reliability and quality metrics workshop scheduled from october 18th-19th, mumbai and 20th-21st october, hyderabad. I'm working with former fda experts for this project. I was looking out for a former fda expert who could cover on quality metrics+undefined Other Responses
We are looking for experts on fda filing process (oral solid dose, medical devices, parenteral packaging) for packaging & devices. Our key areas of expertise requirement are as below:
1. In case of supplier location changes or production contingencies, what is the process for fda filing for approval?
2. How do pharma companies file with fda for same packaging sourced from different manufacturing locations of a single supplier?+undefined Other Responses