Job Description We are currently looking for a QC Compliance Specialist at our manufacturing site in Cork, this is a 12 month FTC role.
The QC Compliance Specialist is responsible for ensuring quality assurance processes and safety protocols are consistently followed within the laboratory environment.
This position ensures the QC laboratory maintains the highest standards of quality and safety, supporting both regulatory compliance and continuous process improvement.
Role Responsibilities: 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 Qualifications 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 Additional Information AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.
Equal Opportunity Employer/Veterans/Disabled.
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