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.
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.
