Senior QA Manager - GMP

Reference Number: 896099-W
Type of placement: Contract, 6 months
Location: Switzerland, North West

Introduction:

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 for a Senior QA Manager for 6 months contract based in Basel area.

The ideal candidate should have 3 years of experience in quality assurance activities as well as sound knowledge of GMP and regulatory environments.

Main Responsibilities:

  • Provide GMP/GDP quality assurance expertise during development and later during commercialization of the products;
  • Prepare GMP/GDP Agreements in collaboration with CMOs and the CMC team;
  • Write, review, and/or approve internal SOPs and other GMP/GDP related documentation;
  • Ensure that medicinal products are designed, developed, manufactured and controlled according to quality standards;
  • Establish a quality risk management approach in projects based on ICH Q9 concepts 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, investigational medicinal products including approval of master process documentation, batch record review, resolution of investigations, and assessment of change controls;
  • Notify management of potential quality and regulatory issues;
  • For assigned projects, provide guidance on the resolution of complaints, testing issues, discrepancies and Out of Specifications, investigations and Corrective and Preventive Actions as needed;
  • Support review and optimization of the company’s pharmaceutical quality system by establishing and preparing review of relevant Key Performance Indicators.

Qualifications and Experience:

  • Advanced University degree in Pharmacy, Chemistry or alternative technical/science university degree;
  • Minimum of 5 years’ experience in different positions like pharmaceutical or chemical development, quality control, analytical development, chemical or pharmaceutical production or similar operational positions in the pharmaceutical industry;
  • Excellent knowledge of GMPs and regulatory environments, ability to interpret and implement quality standards;
  • Strong interpersonal and influencing skills;
  • Excellent verbal and written communication skills in English;
  • Ability to manage multiple tasks with competing priorities;
  • Entrepreneurial mind set combined with cost consciousness;
  • Relevant working/residency permit or Swiss/EU-Citizenship required.

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