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Experience HELM as a unique family business and an attractive employer. Through a constant exchange of ideas, our ultimate goal is to offer our customers future-oriented solutions within our global network. At any time, in any place. This allows us to work proactively and think long-term - in operations, quality management, process optimization, product development and distribution. We are innovation drivers, possibility makers and a reliable partner, all in one.

Manager Quality Assurance (m/f/d)

Date:  Jun 22, 2024
Location: 

Zürich, CH, 8002

Business Unit:  Pharma
Job Function:  Quality Management / HSE
Level of Experience:  Executive


In the business unit Pharma we develop generic drugs. The Swiss Hub in Zürich (HELM Swiss GmbH)  is responsible for the commercial and quality handling of a selection of products for export from Switzerland, including the USA.  We are looking to add to our team a Scientist with international experience, in the function of Quality Assurance Manager (m/f/d).

 

Your tasks:

 

  • Your role involves maintaining, documenting, and enhancing pharmaceutical quality systems to preserve approvals as a distribution and release site for finished dosage pharmaceutical products.
  • Actively managing all quality-relevant processes for finished medicinal products distributed by HELM SWISS in Europe, the Rest of the World, and the USA is a key responsibility in this position.
  • You will play a crucial role in supporting the Responsible Person/FvP in the batch release process of FDF for human use.
  • Assume the responsibilities of the Responsible Person/FvP as a deputy, ensuring a seamless and effective continuation of critical tasks.
  • Your duty includes ensuring compliance with GMP and GDP regulatory and legal requirements, which involves conducting training sessions for employees.
  • Engage in effective communication with customers, manufacturers, and internal stakeholders on various quality-related topics.
  • Provide valuable support to the QA team in inspecting third parties and subcontractors, contributing to the overall quality assurance efforts.
  • Take charge of the preparation, management, and follow-up of customer and authority inspections to maintain regulatory compliance.
  • Play a pivotal role in supporting product launch activities, ensuring a smooth transition and adherence to quality standards.
  • Your involvement in international project teams will contribute to the success and alignment of global quality initiatives.

 

 

Your profile:

 

  • Possessing a degree in pharmaceutical or natural science studies is a fundamental requirement for this role.
  • In addition to your academic background, you bring several years of hands-on experience in Quality Assurance, ideally with prior experience as a Responsible Person in the pharmaceutical industry.
  • Your enthusiasm for collaborating in an international team aligns seamlessly with the collaborative nature of this position.
  • Excellent communication skills are a key attribute we are looking for in a candidate to effectively interact with diverse stakeholders.
  • The role requires a proven track record and references attesting to your successful contributions in similar capacities.
  • Fluency in English is a mandatory requirement, with an additional benefit if you have a B2 level proficiency in German.
  • Familiarity with European and US guidelines in the pharmaceutical industry is highly valued and considered advantageous for this role.

 

 

Every day, each one of us contributes to HELM's success with competence, the highest expertise and unique service. We reward this commitment - not only with international opportunities, possibilities for seminars and further training but also with benefits that offer optimal conditions to reach the perfect work-life balance.

Interested?
Then please apply with all necessary documents via our application portal.

Apply now »