Specialist qc compliance

JobdescriptionRole
Overview: Specialist QC ComplianceThe 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
ResponsibilitiesQuality
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
RequirementsEducation: 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).