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View: 128

Update day: 04-04-2024

Location: Basel Basel-Stadt BS

Category: Quality Assurance / Quality Control

Industry: Staffing Recruiting

Position: Director

Job type: Full-time

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Job content

Head of Quality Assurance

PU Microparticles & FvP/QP

Location: Switzerland, Basel, WSJ-340

About Us

We are committed to delivering high-quality pharmaceutical products to improve the health and well-being of people around the world. We are currently seeking a dynamic and experienced leader to join our team as the Head of Quality Assurance for PU Microparticles & FvP/QP. This is a unique opportunity to play a pivotal role in ensuring the quality and compliance of our pharmaceutical products in a cutting-edge facility in Basel, Switzerland.

Position Overview

As the Head of Quality Assurance, you will be the "Fachtechnisch verantwortliche Person" (FvP), for PU Microparticles in Basel, Switzerland. You will be responsible for maintaining and enhancing our commitment to quality, regulatory compliance, and GMP standards throughout our product development, transfer, and commercialisation processes. This role will require you to lead a dedicated team, manage audits and inspections, and oversee the implementation of our Quality Management System. Your expertise will be essential in ensuring the technical release of locally manufactured products and maintaining our commitment to quality excellence.

Key Responsibilities

  • Act as the FvP, with the authority to issue instructions and make independent decisions in your sphere of activity.
  • Ensure compliance with cGxP standards throughout product development, transfer, and commercialisation.
  • Maintain independence from business with respect to the release of investigational and commercial pharmaceutical products.
  • Manage GMP audits and inspections, including self-inspections and customer audits.
  • Review and approve GMP-relevant documents and deviations, contributing to investigations and CAPAs.
  • Provide oversight on qualification and validation processes.
  • Collaborate with internal and external stakeholders, including Health Authorities.

Qualifications And Skills

  • University degree with a scientific/technological background (e.g., Chemistry, Pharmacy, Biology, Biochemistry, or equivalent).
  • Over 5 years of experience in the release of medicinal products for human use.
  • Qualified Person (depending on local requirements).
  • Expertise in GxP operations, product release activities, and Quality Assurance.
  • Strong leadership, communication, and problem-solving skills.
  • Proficiency in English, French, and German.

What We Offer

  • A challenging and rewarding leadership role in a state-of-the-art pharmaceutical facility.
  • Competitive compensation and benefits package.
  • Opportunities for professional growth and development.
  • A collaborative and inclusive work environment dedicated to quality and compliance.

If you are a results-oriented, experienced Quality Assurance leader with a passion for ensuring the highest standards of quality in pharmaceutical products, we invite you to apply for this exciting opportunity.
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Deadline: 19-05-2024

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