QA Operations / Shop Floor QA Specialist

Meet Life Sciences

Oberwallis

Presencial

CHF 100.000 - 145.000

Jornada completa

hace 12 horas
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Descripción de la vacante

Meet Life Sciences in Visp, Switzerland, is seeking a QA Operations Specialist to support day-to-day GMP manufacturing quality activities onsite.

The role focuses on QA oversight of shop-floor operations, batch record review, deviations, CAPAs, and change controls, with a focus on inspection readiness and regulatory audits.

Ideal candidates have hands-on GMP experience in biotech or pharma, the ability to work cross-functionally, and readiness to join an on-site team in Visp.

Formación

  • Experience in QA Operations or Shop Floor QA within pharma/biotech manufacturing.
  • Strong knowledge of GMP regulations and quality systems.
  • Hands-on batch record review, deviations and CAPAs.
  • Experience supporting manufacturing operations in a regulated environment.
  • Biologics or sterile manufacturing exposure is advantageous.
  • Involvement in regulatory inspections is desirable.

Responsabilidades

  • Provide QA oversight of GMP manufacturing operations, including shop-floor activities.
  • Review batch manufacturing records and GMP documentation.
  • Support batch release readiness, ensuring compliant documentation.
  • Manage deviations, investigations, CAPAs and change controls.
  • Identify GMP gaps and support corrective actions.
  • Collaborate with Manufacturing, QC and Quality Systems teams to resolve quality issues.
  • Support inspection readiness activities and regulatory audits.
  • Ensure processes and documentation comply with GMP requirements.

Conocimientos

QA Operations
GMP Compliance
Batch records
Deviations & CAPAs
Cross-functional collaboration

Descripción del empleo

QA Operations Specialist – Biotech Manufacturing

Contract: Initial 6 months

Start: ASAP

Working arrangement: Onsite

About the Opportunity

Meet Life Sciences is supporting a leading biotechnology manufacturing organisation in Visp, Switzerland, with an ongoing GMP inspection readiness programme.

We are looking for an experienced QA Operations Specialist to support day-to-day manufacturing quality activities, strengthen GMP compliance and ensure operational readiness for regulatory inspections.

Key Responsibilities
  • Provide QA oversight of GMP manufacturing operations, including shop-floor activities.
  • Review batch manufacturing records and associated GMP documentation.
  • Support batch release readiness, ensuring documentation is complete and compliant.
  • Manage and support deviations, investigations, CAPAs and change controls.
  • Identify GMP compliance gaps and support corrective actions.
  • Work closely with Manufacturing, QC and Quality Systems teams to resolve quality issues.
  • Support inspection readiness activities and preparation for regulatory audits.
  • Ensure manufacturing processes and documentation comply with applicable GMP requirements.
Requirements
  • Previous experience in QA Operations or Shop Floor QA within pharmaceutical or biotechnology manufacturing.
  • Strong working knowledge of GMP regulations and quality systems.
  • Hands-on experience with batch record review, deviations and CAPAs.
  • Experience supporting manufacturing operations in a regulated environment.
  • Exposure to biologics or sterile manufacturing would be advantageous.
  • Previous involvement in FDA, Swissmedic or other regulatory inspections is desirable.
  • Ability to work independently and collaborate with cross-functional teams.
  • Availability to work onsite in Visp, Switzerland.
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