Team Lead Quality Assurance Drug Product/EU Qualified Person

Reference Number: 896137-W
Type of placement: Permanent
Location: CH, NW

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 a Team Lead Quality Assurance Drug Product for a permanent position based in Basel area. The ideal candidate should have at least 10 years’ (of which a minimum of 5-years' experience in QA, specifically, as appointed EU Qualified Person in accordance with "Arzneimittelgesetz, §15") experience in different positions like pharmaceutical product development, quality control, analytical development, chemical production or similar operational positions in the pharmaceutical industry, which includes experience in a leadership/line management role.

Main Responsibilities:

  • As Expert Quality Manager, lead and supervise a group of Quality Managers focusing on Drug Product development and later, commercialization of their products;
  • Manage the group/direct reports by setting goals, organizing resources, coaching and providing feedback to direct reports;
  • Provide GMP/GDP expertise thus ensuring that medicinal products are developed, manufactured, packed, labelled, distributed and controlled in accordance with regulatory expectations and applicable quality standards;
  • Oversee all required QA activities to support release of drug products and finished packed commercial products including, approval of master process documentation, batch record review, resolution of investigations and assessment of change controls;
  • Ensure resolution of complaints, testing issues, discrepancies, Out of Specifications (OOS) and Corrective and Preventive Actions (CAPA);
  • Prepare, review, and/or approve internal SOPs and other GMP/GDP related documentation
  • Prepare GMP/GDP Quality Agreements;
  • As the appointed EU QP, take responsibility for the release of IMPs and later, commercial products to the market;
  • Notify management of potential quality and regulatory issues;
  • Support the review and optimization of the company’s pharmaceutical quality system by establishing relevant Key Performance Indicators;
  • Participate in GMP/GDP regulatory authority inspections and support affiliate sites in the implementation of compliant quality systems.

Qualifications and Experience:

  • Advanced University degree in Pharmacy (preferred), Chemistry or alternative technical/science university degree;
  • At least 5-years' experience in Quality Assurance role and specifically, as appointed EU Qualified Person in accordance with "Arzneimittelgesetz, §15";
  • At least 10 years’ experience in different positions like pharmaceutical product development, quality control, analytical development, chemical production or similar operational positions in the pharmaceutical industry, which includes experience in a leadership/line management role;
  • Excellent knowledge of GMP and GDP requirements, ability to interpret and implement quality standards;Sound knowledge of drug product and combination product manufacturing, control, packaging and distribution procedures;
  • Strong interpersonal and influencing skills to facilitate team work and strong cross functional working relationships;
  • Excellent verbal and written communication skills in English and German;
  • 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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