QA Manager GMP/GDP (5211)
QUALITY ASSURANCE MANAGER – 5211 URA
Our client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, committed into delivering products on the market over the next 5 years, is looking a Quality Assurance Manager (GMP) on a contract basis to be based in Basel area.
- Provide GMP/GDP quality assurance expertise during development and commercialization of 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 to adequate quality standards
- Support review and optimization of the company's pharmaceutical quality system for assigned processes.
- Pro-actively participate to the optimization of the quality system by proposing new procedures, tools or modification of existing ones
- 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
- Participate, represent and defend quality activities in CMC team meetings
- 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
Qualifications and Experience:
- Relevant Swiss working/residency permit and/or Swiss/EU-Citizenship required;
- University degree in Pharmacy, Chemistry or alternative technical/science university degree: master level minimum preferred.
- 3+ 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+ 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 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 European language, German or French advantageous