QC Compliance Specialist ( 12 month FTC)
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Job Location:
Monthly Salary:
Posted on:
4 hours ago
Vacancies:
1 Vacancy
Job Summary
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.
US & Puerto Rico only - to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Full-time
Key Skills
About Company
AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuro ... View more
