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 :

• University 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.

Apply :

It is essential that applicants hold entitlement to work in the UK. Please quote job reference 107 907 in all correspondence.