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QA Manager – GMP/GDP

Website Achieva Group Limited

An excellent opportunity has arisen to join a leading pharmaceutical company as a QA Manager – GMP/GDP.

• Provide GMP/GDP quality assurance expertise during development and commercialization of Idorsia’s 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

• University degree in Pharmacy, Chemistry or alternative technical/science university degree
• 3-6 years of experience in different positions like pharmaceutical product development/ quality control/analytical development/ chemical production or similar operational positions in the pharmaceutical industry
• 3-6 years of experience in quality assurance of drug substance and/or drug product
• Knowledge and understanding of drug substance and/or Drug Product development, manufacturing process, quality control, packaging and distribution
• Good knowledge of (c)GMP/GDP’s

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