QA Manager GMP/GDP, Basel

vor 4 Wochen

Basel, Schweiz TN Switzerland Vollzeit

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Responsibilities:
  • Provide GMP/GDP quality assurance expertise during development and commercialization of client’s 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.
  • 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.
  • 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.
  • Support review and optimization of the company's pharmaceutical quality system by preparing review of relevant CMO's Key Performance Indicators.
  • Pro-actively participate to the optimization of the quality system by proposing new procedures, tools or modification of existing ones.
  • Release of DS and DP Bulk as defined in the relevant release SOPs.
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.
  • 5-10 years of experience in different positions like pharmaceutical product development/quality control/analytical development/chemical production or similar operational positions in the pharmaceutical industry.
  • 5-10 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.
  • Fluent verbal and written communication skills in English and at least basic knowledge of an additional European language e.g. German/Italian/French.
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