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Quality Assurance Manager
CK GroupSwitzerlandIl y a plus de 30 jours
Salaire
73,72 CHF –86,44 CHF par heure
Description de posteUniversity degree in Pharmacy, Chemistry or alternative technical / science university degree : master level minimum. 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. Ability to interpret and implement Quality standards. Ability to manage complex projects and prioritize workload according to the project importance. Ability to pro-actively initiate and lead quality activities. Ability to manage multiple tasks with competing priorities. Good interpersonal and influencing skills. Self-confident, assertiveness and autonomy to deal with complex stakeholders / situations. Ability to communicate clearly and professionally both verbally and in writing. Fluent in English and at least basic knowledge of an additional language, German or French advantageous.
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 :