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.

 

Main Responsibilities:

 

  •  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
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