Associate Manager - Mqa

pfizer.dk

Cgmp compliance monitoring
Ebr review and exception assessment
Batch record review
The MQ TS Downstream Associate Manager is responsible for primary contact of quality on the floor, particularly in the Terminal sterilization, Visual Inspection and Packing areas of production and monitor processes for compliance to cGMP standards

Job Summary

  • The MQ TS Downstream Associate Manager is responsible for primary contact of quality on the floor, particularly in the Terminal sterilization, Visual Inspection and Packing areas of production and monitor processes for compliance to cGMP standards.
  • Responsible for ensuring operating state of cGMP compliance in Terminal Sterilization, Visual Inspection and Packaging operations and maintain regulatory compliance in accordance with cGMP practices.
  • Identify gaps and involve in Process and Procedure Simplification, thereby reduce downtime, and increase the Efficiency.

Matching Summary

The MQ TS Downstream Associate Manager is responsible for primary contact of quality on the floor, particularly in the Terminal sterilization, Visual Inspection and Packing areas of production and monitor processes for compliance to cGMP standards.

Skills & Requirements

Must-have

  • cGMP compliance monitoring
  • eBR review and exception assessment
  • batch record review
  • process checks and walkthroughs
  • equipment breakdown assessment
  • handling regulatory auditors

Nice-to-have

  • strong organizational skills
  • attention to detail
  • ability to mentor colleagues

Key Requirements

  • B. Pharm, M. Pharm, MSc. with 6-8 years of experience

Work Rights

Not specified

Tailored Resume

Cover Letter