Quality Control Specialist

3 weeks ago

Dublin, Dublin City, Ireland Cpl Healthcare Full time

Cpl in partnership with our client Pfizer are seeking a Quality Control Specialist (NPI/ES/RMCR) to join the team for a 12month fixed term contingent contract, onsite at their state of the art plant in Dublin, Grange castle.

Job Purpose:

·Support the QC NPI and QCES and RMCR teams in the operational and analytical readiness of new products in and out of Quality Control.

· To lead/author and manage all QC NPI, QCES, RMCR records to support the transfer, validation and testing readiness for all new products into and out of GC including but not limited to change controls, protocol deviations and events, and other investigations as required per project.

· To support with quality systems activities, e.g., audit support, compendial affairs to ensure compliance and adherence to site SOPs, APRRs, Regulatory submissions, queries and repsonses.

Job Responsibilities:

· To lead / manage all records across the QC NPI, QCES, and RMCR teams including and not limited to Change Controls, Commitments, Protocol Deviations and Events and other investigations (ERs, QARs LIRs, RAACs as required) for all qualification/validation and transfers supporting the introduction of new products into and out of the site and any events or deviations associated with RMCR protocol execution.

· This includes authoring investigation reports and supporting assessments as needed to ensure compliance with procedures and driving the identification and implementation of effective corrective actions to support reduction in deviations.

·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.

· Partner closely with customers and stakeholders to understand and deliver on all records within timelines and escalate when necessary.

· Support Key Meetings in QC, e.g., Investigations/ LIR Meetings, Change control meetings, other as required.

·Collate and report out on metrics /due dates to QC Manager as required.

· Support trending and compilation of system reports and audit listings across the teams as required and in a timely manner.

· Participate in the audit program as required and carry out cGMP compliance area walkthroughs as applicable ensuring site is always audit ready.

· Participate in and support IMEX processes (Visual Management, Standard Work, CI).

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

·Support regulatory filing submissions, queries and responses for new products.

·Support Laboratory Inspections and Audits.

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

Core Competencies:

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

·Experience and track record of successful project management.

·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. (QTS, Vault, PDOCS, LIMS, Empower, Chromeleon, Trackwise, Generis Cara Documentation).

·Excellent communications skills.

·Technical writing.

·Competent in basic and intermediate level statistics.

· Adhere to all HR Policies as appropriate.

Education:

·Minimum BSc Degree and 3+ years' experience in a Biopharmaceutical or Pharmaceutical cGMP-manufacturing environment required, or equivalent.

· Previous relevant Quality experience in deviations, events and investigations as detailed above in the job responsibilities section, within a QA/QC GMP environment in a Pharma/Biotech company.

·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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