Quality Assurance Manager

CK QLS are recruiting for a (Senior) QA Manager, that demonstrate expertise in a specific field with a proven experience in the pharmaceutical industry within quality assurance of drug substance and / or drug products, on a 12 month contract basis.

RESPONSIBILITIES AND TASKS :

• Provide GMP / GDP quality assurance expertise during development and commercialization of clients products.
• Ensure all required quality activities are initiated and completed according to the development stage.
• Ensure that medicinal products are designed, developed, manufactured and controlled according to adequate quality standards.
• For assigned projects, provide guidance on the resolution of complaints, testing issues, deviations, discrepancies and Out of Specifications (OOS), investigations and propose Corrective and Preventive Actions (CAPA) as needed.
• Establish a quality risk management approach in projects based on six sigma concepts and training to ensure that quality is understood and managed by all stakeholders throughout the product life cycle.
• Manage all required activities to support release of active ingredients, commercial products and / or investigational medicinal products including approval of master process documentation, batch record review and assessment of change controls.

REQUIRED QUALIFICATIONS AND EXPERIENCE :