QA Specialist

m/f/d, Basel-Stadt

We are seeking an experienced Drug Product Quality Assurance professional to join our team and support GMP-compliant manufacturing operations. In this role, you will act as a key QA representative within cross-functional project teams, ensuring quality oversight throughout the drug product lifecycle. You will serve as a primary point of contact for quality-related topics, regulatory interactions, and continuous improvement initiatives, contributing to the maintenance and further development of an effective Quality Management System.

Location: Visp

Contract duration: 31.07.2026

Responsibilities:

  • Act as QA representative in Project teams and represent QA in meetings
  • Act as QA contact for specific topics and realize the interface for DRs and CRs
  • Act as point of contact for Drug Product QA related questions, topics and complaints from customers related to the manufacturing operations
  • Support and approve risk assessments or regulatory specific risk or gap assessments.
  • Review and release product specific documentation such as process descriptions and workflows, recipes, manufacturing protocols, transfer documents, test plans, parameter lists, etc.
  • Represent Drug Product QA topics during regulatory inspections.
  • Support continuous improvement programs to establish an effective Quality Management System for Visp DPS.
  • Represent Quality Assurance in cross-functional teams, establish and maintain interfaces with the Manufacturing teams, QC, Support Functions, Project- and Site Engineering project / technology transfer to effectively execute tasks related to Drug Product processes.
  • Assess, review and approve quality records and release files/dossiers e.g. deviations, change control, CAPAs, investigations, effectiveness checks, extensions, complaints, APR/PQRs, in line with current local SOPs.

 

Requirements:

  • University degree or equivalent in Chemistry / Biology / Biotechnology or a related field
  • Long-term experience working in the GMP environment of the pharmaceutical industry
  • Experience working in a QA department Drug Product

Sounds like a great job?
Then we look forward to receiving your complete application documents through our online application form.

When applying by email, the sender agrees that his or her data will be used in accordance with our data privacy policy.

Find more vacancies at: coopers.ch

Job profile
  • Life Sciences - Quality Management
  • Basel-Stadt
  • Contracting
  • Full Time
  • Immediately - 31.07.2026
  • Quality Assurance, GMP, Drug Manufacturing
Agnieszka Kawalec

Sounds interesting?
Simply click "Apply now" and I will get back to you.

Agnieszka Kawalec
Talent Acquisition Consultant
+41 41 632 43 54
Agnieszka.Kawalec@coopers.ch

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