Senior Quality Assurance - CSV specialist
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.
Senior Quality Assurance - CSV specialist
For our client based in Vaud canton and specializedin biopharmaceutical area, we’re looking for a Senior QualityAssurance - CSV specialist . Minimum 10 years in CSV/QA CSVwith Quality experience. ManageQuality oversight for computerized systems validation and the dataintegrity program & support QA a...
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