Quality Control RMCR & Transfer Specialist

Cpl in partnership with our client Pfizer are seeking a Quality Control RMCR & Transfer Specialist Role to join the team for an 11-month fixed-term contract at their state-of-the-art Dublin, Grange Castle site. This role carries a hybrid working model. 

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 QC reference material and control reagent (RMCR) programs for both established and upcoming new products in Pfizer Grange Castle.

·      Support external analytical method transfers for both established and new products.

·      Support regulatory activities including those related to review of analytical sections in both new and updated submissions as well as query responses.

·      Support Pfizer sites, board of health laboratories and Official Medicines Control Laboratory (OMCL) and National Control Laboratory (NCL) to enable local market testing as part of dossier pre-approval and product release requirements.

·      Support technical document initiation and updates required to meet regulatory and/or project timelines. Support test method specification updates.

Reporting Structure

QC Lead

⇧

QC Senior Manager

⇧

QC RMCR Lead

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QC Specialist

About the Role / Job Responsibilities

·      Liaise with customers both internal and external to support overall method transfer processes.

·      Liaise with customers both internal and external to provide RMCR supply to support testing. 

·      Provide technical support & RMCR to all new country launches.

·      Technical author, review, and critique of analytical/regulatory leaflets for all new filing applications for established and new products.

·      Address product analytical queries from global regulatory teams in support of new and updated submissions.

·      Co-ordination and technical review of responses to agency questions on analytical methods & reference materials.

·      Support importation testing queries and support for rest of world labs via country affiliates and from packing sites.

·      Support the implementation of analytical methods in Official Medicines Control Laboratories (OMCL) and National Control Laboratories (NCL) as part of product market release.

·      Technical/analytical support to Board of Health Labs and OMCL/NCL laboratories on analytical queries related to products.

·      Representative/active participant on cross functional analytical and product teams.

·      Support operations of the Quality Control testing laboratories as requested by QC management for example assay execution or data review.

·      Support teams to provide QC assessments/information related to analytical test procedures/data trends/other analytical data as required.

·      Support opportunities for Continuous Improvement within the team and embrace the company’s culture to own and drive any activities associated with delivering these improvements.

·      Provide support to agency site inspections as required.

·      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 RMCR Manager / QC External Support Senior 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.

·      Minimum of 1-2 years’ work experience within a QA/QC GMP environment in a pharma/ biotech company.

·      Proven knowledge in analytical techniques, analytical instrumentation theory and practice.

·      Proven ability to recognise problems with equipment, methods, software, procedures and resolve the issues.

·      Experience with Quality and Laboratory systems an advantage.

·      Excellent communication, and interpersonal skills.

·      Proven success in proactive project management.

·      Experience in managing multiple projects to tight timelines 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 functional teams.

·      Ability to work independently, as well as a member of a team in a dynamic, fast-paced environment.

People/Values:

·      Demonstrate Company Values and Behaviors.

·      Adhere to all HR Policies as appropriate.

·      Recognition is actively practiced by you and across the team.

·      Proactive engagement with key stakeholders.

·      Best practices developed and shared with other teams /sites.

·      Best practices actively sought and copied.

·      Proactive & effective communication within and across teams.

·      Support use of Lean tools and IMEX systems within the team to manage workload and implement continuous improvements.