QA Manager (GDP/GMP)
QLS are recruiting for a QA Manager (GMP/GDP) to join a Innovative Pharmaceutical company based in Basel on a contract basis for 12 months.
- Provide GMP/GDP quality assurance expertise during development and commercialization of Company’s products
- Ensure all required quality activities are initiated and completed according to the development or commercial stage
- Ensure that medicinal products are designed, developed, manufactured and controlled according toadequate quality standards
- Support review and optimization of the company's pharmaceutical quality system for assigned processes.
- 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
- Notify CMC team and management of potential quality, regulatory and lead time issues
- Assist in the conduct of GMP/GDP audits at 3rd party sites when needed
- Preparation of GMP/GDP Agreements in collaboration with CMOs and the CMC team
- Write, review, and/or approve internal SOP’s and other GMP/GDP related documentation
- University degree in Pharmacy, Chemistry or alternative technical/scienceuniversity degree: master level minimum preferred.
- 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.
- Qualification to become an EU Qualified Person (and/or FvP) an added value.
- Good knowledge of (c)GMP/GDP’s
- Ability to interpret and implement Quality standards
- Ability to pro-actively initiate and lead quality activities
- Ability to manage multiple tasks with competing priorities
- Self-confident, assertiveness and autonomy to deal with complex situations
- Fluent in English and at least basic knowledge of an additional European language, German or French advantageous
For more information or to apply for this position, please contact Adrien on 0041 (0) 800 106 106 or email email@example.com. Please could you send any correspondence in English. Please quote job reference 56158 in all correspondence.