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.