QC Compliance Specialist ( 12 month FTC)
AbbVie View all jobs
- Cork
- Permanent
- Full-time
- Monitor and ensure compliance with laboratory quality control procedures and safety guidelines.
- Lead the Laboratory Compliance and Safety Walkdown programmes to ensure compliance with internal and external regulations.
- Lab Investigation writer
- Implement effective CAPA
- Generation of QC department PQR reports on a biannual basis in line with site PQR schedule
- Support QC department audit readiness for internal and external inspections.
- Collaborate with management and other departments to improve lab processes and resolve compliance issues.
- Prepare compliance reports, SOPs, and maintain accurate records.
- Participate in risk assessments and hazard analyses.
- Identify and support Continuous Improvement activities within the QC department
- Support QC Snr Support Analyst through Compliance Wire administration and onboarding training as needed
- QC Department Safety lead on site Green Button (safety) Team
- Lead QC safety team to drive lab safety improvements
- Primary degree in analytical science or in an equivalent science-based discipline
- 3 years minimum experience in pharmaceutical quality control laboratory. Experience of Trackwise and applicable modules ER, CP and audit an advantage.
- Knowledge of QC regulations, European and FDA regulations
- Experience with QC analytical methods and procedures
- Knowledge of QC equipment and data integrity principles