Quality Assurance Manager

Fairfield, NJ 07004

Posted: 10/07/2019 Industry: Pharma Job Number: 9228

SUMMARY

We are seeking a highly motivated individual to join us as a Quality Assurance Manager. This individual will have the responsibility for Quality aspects related to Quality Systems in the packaging facility. The Quality Assurance Manager will ensure compliance with current Good Manufacturing Practices (cGMP) as they pertain to the local regulation and exporting countries regulation as applicable (such as FDA, MHRA, EMA, Health Canada).



RESPONSIBILITIES

  • Quality Assurance management:



  • Documentation control (master batch record, specification and method)



  • Batch record review and product disposition



  • Investigations, complaints, deviations, CAPAs, APRs



  • Production and Pharmaceutical Development support



  • APRs, GMP training and SOP review



  • Validation / qualification documentation review and approval



  • QA Operations - inspection, sampling, and review of incoming materials, perform AQL inspections, support and drive compliance throughout the site



  • Develop, maintain, and enhance training programs and systems



  • Driving key compliance initiatives such as, Training Program Enhancements, Quality Documentation System Enhancements, other identified initiatives.



  • In collaboration with the Quality Assurance team, the Quality Assurance Manager will be responsible for: i). Quality Compliance management: ii). All audits, internal, external - regulatory, client and vendor iii). Vendor management program iv). QA Agreements with clients & contractors v). License renewals





QUALIFICATIONS

  • 7+ years relevant experience



  • Experience with FDA Audit



  • Extensive knowledge of US and EU current Good Manufacturing Practices



  • Experience with a CDMO would be preferable

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