GMP Operations and Compliance Specialist

vor 8 Stunden

Neuenburg, Neuenburg, Schweiz Randstad Vollzeit
About the Role

We are seeking an experienced Quality Assurance Senior Expert to join our team at Randstad. In this critical role, you will be responsible for providing expert support in quality assurance within the Quality Ops organization.

As a Quality Assurance Senior Expert, you will be tasked with reviewing deviations in production events, preparing and evaluating controlled documentation, and attending relevant meetings. You will also be responsible for respecting the escalation process and ensuring completion of relevant training and software access management according to Takeda policies.

Responsibilities:

  • Provide expert support in quality assurance within the Quality Ops organization.
  • Review deviations in production events within quality systems (e.g., Trackwise) to verify acceptability and adherence to standard procedures and regulatory requirements.
  • Prepare, evaluate, and approve controlled documentation revisions and creations.
  • Attend relevant meetings to perform these tasks.
  • Respect the escalation process.
  • Ensure completion of relevant training and software access management according to Takeda policies.

Requirements:

  • Possess a strong academic background in technical and scientific fields (bachelor's degree or higher).
  • Hold 2-3 years of operational experience in cGMP within a Quality Ops department on a pharmaceutical production site for sterile injectable products.
  • Demonstrate holistic knowledge of production processes, from cell culture to aseptic filling.
  • Familiarity with quality references (cGMP) and quality systems (deviations, CAPA, change control, training, documentation, etc.).
  • Strong writing skills for documents in French and/or English.
  • Proficiency in Microsoft Office.
  • Excellent teamwork and agility skills.

Work Environment:

This role requires a minimum of 4 days on-site presence. The employee will report to the QA manager but work interactively with Manufacturing, Engineering, Sterility Assurance, Quality Ops, Training, etc.

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