Come join a Global leader in Medical Manufacturing!
From process to product design: manufacturing to logistics, this company is innovative and passionate about bringing world class products to their customers.
- Performs the QA review and approval of the following GMP documentation as it relates to the processing equipment and facility to which the position is aligned.
- You will also be required to change requests, batch records, and provide associated documentation accordingly.
- Will be responsible for performing quality investigations that include but not limited to: deviations, product complaints, protocols and processing reports.
- Will be required to follow standard operating procedures.
- Accountability for supplier management including but not limited to Annual Assessments, Quality Assurance Agreements, and KPI’s.
- Minimum of five (5) years' experience in the pharmaceutical industry and/or FDA experience with at least a minimum of three (3) years' experience in Quality Assurance/Compliance.
- Preferred minimum of seven (7) years’ experience in QA/Regulatory Compliance in the pharmaceutical industry.
- Strong knowledge of global regulatory and cGMP requirements, industry best-practices.
- Strong familiarity with production operations.