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Quality Assurance Manager

  • Contract
  • Basel, Switzerland
  • CHF72 - CHF77.96 per hour USD / Year
  • Salary: CHF72 - CHF77.96 per hour

Website Achieva Group Limited

A current vacancy as a QA Manager GMP/GDP with a leading pharmaceutical company is available in Switzerland.
 
Our client is looking for candidates based in Switzerland / EU passport holders for an initial 6-month, full time contract.
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

Candidate’s Requirements:

  • 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
  • Self-confident, assertiveness and autonomy to deal with complex stakeholders/situations
  • Fluent in English and at least basic knowledge of an additional European language, German or French advantageous

For more information, please contact Fandi Hatib on +44 1727 817 600 or email fhatib@achieva.co.uk
 

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