Manager External Supply QA

Manager External Supply QA

Bachem

Bubendorf, Switzerland

Your tasks:

  • Qualify and periodically re-evaluate supply chains of critical materials and contract laboratories for GMP API manufacture and release.
  • Map the supply chain for critical materials and maintain appropriate material documentation in accordance with internal, customer, and authority/regulatory requirements.
  • Lead through supply chain changes (e.g., supplier, manufacturer, or raw material manufacturing process change).
  • Negotiate supplier quality agreements.
  • Establish a supplier corrective action request (SCAR) system to identify and address issues to improve the quality of the supply chain.
  • Develop the supplier quality management system to meet the evolving needs of our organization and our customers, as well as the industry that assures the adequacy and quality of raw materials, including chemical and technical materials.

Your profile:

  • Bachelor or Master degree in life sciences or pharmacy including basic knowledge in Organic Chemistry.
  • Minimum two years of experience in an GMP environment in quality assurance, quality control, or manufacturing, preferably with APIs.
  • Experience and affinity in working with application software (e.g. MS Office, eQMS, DMS, SAP, or similar).
  • Excellent communication and negotiation skills in English - proficiency in German is beneficial.
  • Dedicated, self-dependent personality, finding it easy to cope with an intercultural working environment with a hands-on attitude and the ability to get things done.
  • Ability to take a pragmatic approach within the available flexibility and develop individual solutions without compromising on quality.

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