The Specialist QC Compliance acts as a Subject Matter Expert (SME) responsible for ensuring that Quality Control (QC) processes adhere to regulatory requirements, cGMP expectations, and site procedures. The role focuses on driving continuous improvement, maintaining data integrity, and managing quality events within a fast-paced biotechnology or pharmaceutical environment.
...
Jobdetails
Zusammenfassung
- Yverdon-les-Bains, Waadt
- Temporär
veröffentlicht am 28. mai 2026
- Referenznummer
- 25208
nimm Kontakt mit uns auf
Wir sind hier, um dir bei deinen Fragen zu helfen.
M
Margot Ferraton
randstad operational
We find, nurture, and connect uniquely skilled talent with employers when they need it, building successful teams that scale as their business grows while positioning individuals for rewarding careers and businesses for operational success.
Jobdetails
Role Overview: Specialist QC Compliance
Key Responsibilities
Quality Systems Management: Oversee, document, investigate, and close quality events. Ensure the timely execution of deviations, root cause analyses, CAPAs, change controls, and periodic reviews.
Data Integrity: Coordinate the QC Data Integrity Plan, conduct risk assessments, implement mitigations, and deliver data integrity training to the team.
Equipment & Validation: Support the qualification and validation of QC equipment and related software (URS, protocols, risk assessments, reports). Track equipment work orders, maintenance, and calibration records.
Operational Support: Assist with QC sample management (reception, aliquoting, LIMS entry), material release, and monthly reviews of environmental monitoring system (EMS) alarms.
Documentation & Audits: Author, review, and maintain SOPs and related quality documents. Participate in audit/inspection readiness and address any observations.
Regulatory Watch: Monitor and coordinate the implementation of regulatory and pharmacopoeial updates.
Candidate Requirements
Education: MSc in Biotechnology, Pharmaceuticals, Engineering, or equivalent industry experience.
Experience: Minimum 5 years in a GMP environment, with at least 3-5 years specifically in Quality Control.
Technical Skills: Deep expertise in quality systems (Deviations, CAPA, Change Controls), hands-on equipment software qualification, and strong troubleshooting abilities.
Soft Skills: Proactive, rigorous, and team-oriented with a proven ability to build trust and work in highly regulated environments.
Languages: Fluent in both French and English (C1 level or equivalent).
Role Overview: Specialist QC Compliance
The Specialist QC Compliance acts as a Subject Matter Expert (SME) responsible for ensuring that Quality Control (QC) processes adhere to regulatory requirements, cGMP expectations, and site procedures. The role focuses on driving continuous improvement, maintaining data integrity, and managing quality events within a fast-paced biotechnology or pharmaceutical environment.
Key Responsibilities
Quality Systems Management: Oversee, document, investigate, and close quality events. Ensure the timely execution of deviations, root cause analyses, CAPAs, change controls, and periodic reviews.
Data Integrity: Coordinate the QC Data Integrity Plan, conduct risk assessments, implement mitigations, and deliver data integrity training to the team.
Equipment & Validation: Support the qualification and validation of QC equipment and related software (URS, protocols, risk assessments, reports). Track equipment work orders, maintenance, and calibration records.
Operational Support: Assist with QC sample management (reception, aliquoting, LIMS entry), material release, and monthly reviews of environmental monitoring system (EMS) alarms.
Documentation & Audits: Author, review, and maintain SOPs and related quality documents. Participate in audit/inspection readiness and address any observations.
Regulatory Watch: Monitor and coordinate the implementation of regulatory and pharmacopoeial updates.
...
Candidate Requirements
Education: MSc in Biotechnology, Pharmaceuticals, Engineering, or equivalent industry experience.
Experience: Minimum 5 years in a GMP environment, with at least 3-5 years specifically in Quality Control.
Technical Skills: Deep expertise in quality systems (Deviations, CAPA, Change Controls), hands-on equipment software qualification, and strong troubleshooting abilities.
Soft Skills: Proactive, rigorous, and team-oriented with a proven ability to build trust and work in highly regulated environments.
Languages: Fluent in both French and English (C1 level or equivalent).
