QC NPI Specialist

3 weeks ago

Dublin, Dublin City, Ireland Cpl Full time

Cpl in Partnership with our client Pfizer are seeking a QC NPI Specialist to join the team for a 12 month fixed term contingent contract in their state of the art site in Dublin, Grange Castle.

Job Purpose:

· Coordinate the introduction of testing capability for new products within Quality Control.

· Lead the qualification/validation and transfer of methods supporting the introduction of new products to the site.

· Project management of all quality control activities required for the introduction of new products to the Quality Control department.

· Support regulatory submissions of new products by coordinating and contributing to content reviews and data verification of CTD leaflets where the Quality Control organisation has an ownership stake.

· Report to internal and external stakeholders, inclusive of site project management leads, senior management, contract sites, and other Pfizer sites as required.

Job Responsibilities:

· Project management of the introduction of testing capability for new products within Quality Control, inclusive of raw materials, biological, microbiological and chemical in-process and release testing for drug substances and drug products.

· Report project updates to the QC Manager and Site/Network Project/Product Leads.

· Liaise with all internal and external stakeholders, inclusive of QC Laboratories, QA, Stability, R&D, Manufacturing Operations and Tech Services, Supply Chain, Regulatory, CMOs as appropriate.

· Lead all activities involved in the verification, qualification, validation and transfer (as appropriate) of test methods associated with new products according to ICH guidelines.

· Write/review and approve analytical gap assessments, protocols, and reports for validation/transfer activities.

· Author/review/approve and resolve validation and transfer deviations.

· Support statistical approaches to setting of acceptance criteria for validation/transfer.

· Support regulatory filing submissions for new products, including authoring sections of the CTD and coordinating and contributing to content reviews and data verification of CTD leaflets where the Quality Control Organisation have an ownership stake.

· Assist in the preparation and review of area documentation e.g. SOP's, Forms, sampling and analysis plans, product specifications, etc.

· Work with EHS to co-ordinate and complete chemical approvals and safety risk assessments associated with new materials and methods for new product testing activities.

· Troubleshoot laboratory methods and instrument problems.

· Provide routine analytical and technical support to contract test labs as part of method transfer activities.

· Facilitate training of analysts on new technologies.

· Perform and assist in additional duties as directed by the QC Manager.

· Support Laboratory inspections and audits.

· Support Annual Product Quality Reviews for validation of test methods.

Core Competencies

· A self-starter with the ability to function independently and productively.

· Experience and track record of successful project management.

· Experience in managing multiple projects and reporting regularly to management and senior management within the organisation.

· Communicate technical and schedule risks and required resolutions in a positive and proactive manner.

· Experience with technical elements of the analytical method validation and transfer process.

· Expertise and technical competence in GMP bioanalytical testing and instrumentation – theory and practice (e.g HPLC, GC, CE, Spectroscopy, cell based methods, biological/antibody based methods and others).

· Familiarity with pharmacopoeias.

· Experience with Lab systems an advantage. (LIMS, Empower, Chromeleon, Trackwise, Generis Cara Documentation).

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

· Excellent communications skills.

· Technical writing.

· Competent in basic and intermediate level statistics.

Educational background

· Minimum BSc Degree and 5+ years experience in a Biopharmaceutical or Pharmaceutical cGMP-manufacturing environment required, or equivalent.

· Project management qualification is desirable.

· Previous experience in a method transfer role is desirable.

· Experience with regulatory submissions and query responses is desirable.

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