QA Operations specialist, Visp

Vor 2 Tagen


Visp, Schweiz TN Switzerland Vollzeit

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Proclinical is seeking a QA Operations Specialist to join our client's team in Visp. In this role, you will be a key player in ensuring quality assurance across various cross-functional teams, focusing on Drug Product processes. This position is ideal for someone with a background in QA who is eager to engage with daily manufacturing operations.

Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.

Responsibilities:

  • Serve as the main contact for QA-related inquiries and issues in manufacturing operations.
  • Maintain QA oversight on the shop floor, including regular cleanroom presence.
  • Evaluate, review, and approve GMP documents and quality records such as SOPs, risk assessments, deviations, investigations, CAPAs, change controls, and executed MBRs.
  • Represent QA during internal, customer, and regulatory inspections and audits.
  • Provide GMP-related training to operations personnel.
  • Support continuous improvement initiatives to enhance the Quality Management System.

Key Skills and Requirements:

  • Advanced degree in biotechnology or a related field.
  • Experience in a GMP-regulated environment, particularly in aseptic manufacturing and within a Quality Unit.
  • Ability to collaborate with stakeholders across various departments and management levels.
  • Proficiency in English; German is a plus.
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