Senior Quality Assurance (QA) Manager

37856
  • €85,000.00 EUR
  • Germany
  • Permanent

Walker Cole International is searching for a Senior Quality Assurance (QA) Manager to join a leading Pharmaceutical business in the Saxony region. The role holder will be responsible for ensuring GMP (Good Manufacturing Practice) is maintained across site operations, and maintain contact with the regulator to ensure activities are in compliance with all relevant regulatory guidelines.

Your responsibilities will be to:

  • Lead the Quality Operations on site, ensuring Good Manufacturing Practice (GMP) is maintained.
  • Maintain and improve existing quality processes to ensure continuous operational compliance. 
  • Strategically plan both internal and external audits and complete the internal audits as per the annual schedule. 
  • Host regulatory audits from ANVISA, FDA, EMA, ZMA, Russian Authorities.
  • Facilitate actions and maintain compliance to the systems for change controls, Corrective and Preventive Actions (CAPA's), deviations and complaints. 
  • Lead operational QA activities including investigating deviations, root cause analysis and batch record review.

The successful Quality Manager will have:

  • 5 + years of experience in Quality Assurance within the Pharmaceutical and Life Sciences industry.
  • Strong working knowledge of GxP requirements. 
  • Experience managing a team of QA professionals in a commercial manufacturing environment. 

Quality Assurance | QA | Pharmaceutical | CAPA | Corrective and Preventative Action | Quality | eQMS | PQS | Pharmaceutical Quality System | Batch Release | GMP | Good Manufacturing Practice | QMS | Quality Management System | GxP | Audit | Manager | Team Lead | ANVISA | FDA | EMA | ZMA | Change Control | Deviation | Root Cause Analysis | GEMBA | Oral Solid Dose | Tablets | Capsules | Steriles | Aseptic | Inhaled | Biologics | Biopharmaceutical | Vaccine

Christopher Sowden Founding Director

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