Walker Cole International have been retained to search for a Director of Quality Assurance for a leading pharmaceutical company in the Baden-Württemberg region. The role holder is responsible for ensuring that GMP (Good Manufacturing Practice) is adhered to throughout the site and maintains liaison with the regulator to ensure activities comply with all relevant regulatory guidelines.
Your tasks will be :
* Manage on-site quality operations and ensure compliance with Good Manufacturing Practices (GMP).
* Maintain and improve existing quality processes to ensure ongoing operational compliance.
* Strategically plan both internal and external audits and conduct the internal audits according to the annual plan.
* Conduct regulatory audits of ANVISA, FDA, EMA, ZMA and Russian authorities.
* Facilitate action and ensure compliance with change controls, corrective and preventive actions (CAPAs), deviations, and complaints systems.
* Lead operational QA activities including non-conformance investigation, root cause analysis, and batch record review.
The successful Director of Quality Assurance has :
* 10+ years of quality assurance experience in the pharmaceutical and life sciences industries.
* In-depth knowledge of GxP requirements.
* Experience leading a team of QA professionals in a commercial manufacturing environment.
Quality assurance | Quality assurance | Pharma | CAPA | Corrective and preventive measures | Quality | eQMS | PQS | Pharmaceutical Quality System | Batch release | GMP | Good Manufacturing Practices | QMS | Quality management system | GxP | exam | Managers | Team leader | ANVISA | FDA | EMA | ZMA | Change control | Deviation | Root cause analysis | GEMBA | Oral fixed dose | tablets | Capsules | Sterile | Aseptic | Inhaled | Biologics | Biopharmaceuticals | Vaccine
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