Cpl in partnership with our client Pfizer are seeking a Quality Control Reference Material Specialist to join the team in their state of the art site in Grange Castle, Dublin for a 12 month fixed term contract.
Quality Control Reference Material Specialist
Your role will be in the Quality Control Department in Pfizer Grange Castle as part of an expanding and diverse team of welcoming and supportive colleagues. You will be directly involved in the manufacture, qualification and supply of multiple reference materials and antibody solutions used to test and release Pfizer medicines across the world.
This is an exciting opportunity to join a world class facility, which is dedicated to bringing therapies to the market that will significantly improve patients’ lives.
Job Purpose
Support quality control reference standard and control programs for both established and upcoming new products in Pfizer Grange Castle. You will 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 for both new and established programs.
About the Role
• Support all activities required for the introduction of new reference material programs to Quality Control Grange Castle.
• Ship reference material and critical reagents to external customers using the onsite shipping process.
• Liaise with customers both internal and external to Pfizer to support overall reference material management process.
• Support qualifications/re-qualifications of reference material and critical reagents in conjunction with Grange Castle QC laboratory teams and within an IMEX framework.
• Management of and support to critical reagents/reference standard supply/inter country shipments to ensure continued supply to all markets, contract manufacturing sites and board of health customers.
• Use the Network RMCR Digital system, to manage customer requests, inventories and schedule tasks to load new lots.
• Liaise with external contract sites to coordinate testing results for Re-valuations of current lots and the qualification of new lots.
• Prepare aliquots of all antibodies and any other reference material as required.
• Support opportunities for Continuous Improvement and embrace Pfizer’s culture to own and drive any activities associated with delivering these improvements.
• 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.
• Perform and assist in additional duties as may be directed by QC Manager.
About You
To be successful in this role you will require:
• B.Sc. degree in biological/chemical sciences, business, or other related technical degree or equivalent experience in regulated industry. (Will consider recently graduated candidates)
• Excellent communication, and interpersonal skills.
• Proven ability to communicate problems and required resolution in a positive and proactive manner.
• Self-directed, self-motivated with a demonstrated record in project accountability.
• Ability to work independently, as well as a member of a team in a dynamic, fast-paced environment.