Quality Control Reference Material Specialist
4 days ago
Cpl in partnership with our client Pfizer are seeking a Quality Control Reference Material Specialist to join the team for an 11 month fixed term contract with hybrid working model at their Dublin, Grange Castle site.
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 digital systems to manage reference materials and critical reagents.
*Manage digital systems to pull and analyse data for the QC laboratories.
*Perform statistical analysis to evaluate QC critical reagents.
*Manage the automation of statistical digital systems to generate control charts.
Liaise with customers both internal and external to Pfizer to support overall reference material and critical reagent data management.
Support qualifications/re-qualifications of reference material and critical reagents in conjunction with Grange Castle QC laboratory teams and within an IMEX framework.
Drive introduction of new technologies into the reference materials team to support supply of reference materials and critical reagents to internal and external customers.
Liaise with external contract sites to coordinate testing results for Re-valuations of current lots and the qualification of new lots.
Support opportunities for Continuous Improvement and embrace Pfizers 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, 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.
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.
Demonstrated success in networking across sites/functional teams both internal and external to site.
Ability to work independently, as well as a member of a team in a dynamic, fast-paced environment.
Skills: pharmaceutical statistics computer science
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