Regulatory Compliance Specialist
3 days ago
Cpl in partnership with Pfizer are seeking a Quality Control Reference Material Specialist to join the team for an 11 month fixed term contract at their Dublin site. This role is part of the expanding and diverse Quality Control Department in Pfizer Grange Castle.
About the Role- Support quality control reference standard and control programs for established and new products in Pfizer Grange Castle.
- Coordinate and execute activities to support the production, qualification and supply of reference materials and critical reagents for use in Quality Control testing while maintaining regulatory compliance.
- Digital Systems Management: Support digital systems to manage reference materials and critical reagents.
- Data Analysis: Manage digital systems to pull and analyse data for the QC laboratories.
- Statistical Analysis: Perform statistical analysis to evaluate QC critical reagents.
- Automation: Manage the automation of statistical digital systems to generate control charts.
- Customer Liaison: Liaise with customers both internal and external to Pfizer to support overall reference material and critical reagent data management.
- Qualification and Re-qualification: Support qualifications/re-qualifications of reference material and critical reagents in conjunction with Grange Castle QC laboratory teams and within an IMEX framework.
- New Technologies: Drive introduction of new technologies into the reference materials team to support supply of reference materials and critical reagents to internal and external customers.
- Contract Site Coordination: Liaise with external contract sites to coordinate testing results for Re-valuations of current lots and the qualification of new lots.
- Continuous Improvement: Support opportunities for Continuous Improvement and embrace Pfizer's culture to own and drive any activities associated with delivering these improvements.
- cGMP Implementation: Implement and adhere to appropriate levels of cGMP within the team and promote safety awareness and the established culture of incident and injury free within the area.
This is an exciting opportunity to work in a world class facility dedicated to bringing therapies to the market that will significantly improve patients' lives.
About You- A B.Sc. degree in biological/chemical sciences, statistics, computer or other related technical degree or equivalent experience in a regulated industry.
- Minimum of 2 years working experience in a digital support role in the Pharmaceutical/Biotech industry or equivalent environment.
- Excellent communication and interpersonal skills.
- Proven success in proactive project management.
- Experience in managing multiple projects and reporting regularly to management within the organisation.
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