Senior Quality Assurance - CSV specialist

Randstad
Orbes, Vaud, CH
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Jobdescription

For our client based in Vaud canton and specializedin biopharmaceutical area, we’re looking for a Senior QualityAssurance - CSV specialist

Responsability

ManageQuality oversight for computerized systems validation and the dataintegrity program & support QA activities for systemintroduction / upgrades, ensuring compliance with quality policies,cGMP, EU / US, and Swiss regulations.

Oversee daily quality for GxPIT, CSV, and automated systems(SISA).

  • Act as the main QA contact forcompliance and data integrity
  • Review / approveGxP IT, CSV, and SISA SOPs to ensure regulatorycompliance.
  • Ensure compliance with cGMPs andsupport Commissioning & Qualificationactivities.
  • Review / approve URS, designdocumentation, audit trails, deviations, investigations, and CAPAplans.
  • Align with Global QA CSV organizationand support inspection readiness.
  • Collaboratewith SMEs to anticipate and handle issuespromptly.
  • Promote cGMP understanding andapplication among BioPlant employees.
  • Interpretand implement GMP and regulatoryrequirements.

Profile

  • Academic degree in natural / appliedsciences (Pharmacy, Chemistry, Biotechnology,Engineering).
  • Minimum 10 years in CSV / QA CSVwith Quality experience.
  • In-depth knowledge ofcGMP, international regulations, and validationactivities.
  • Experience with internationalinspections.
  • Strong analytical,problem-solving, and communicationskills.
  • Fluent in French andEnglish.
  • Vor 30+ Tagen
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