QA Specialist

QA Specialist

Pfizer

Dublin, Ireland

Job Purpose:

To ensure that Drug Substance is manufactured and tested to cGMP requirements in the Grange Castle facility and to support the review and disposition of batches.

Job Responsibilities:

• Prepare batch disposition files for QP approval/disposition including recommendation of batch disposition decisions.
• Review all batch manufacturing records (paper/electronic) and associated manufacturing deviations in a timely manner and in accordance with release schedules.
• Ensure that production instructional documentation (SOPs and batch records) are up to date, compliant, and supports RFT (right first time) production, and that all in -process control limits and specifications have been met.
• Review all operational SOP’s, forms, protocols and reports, and any related documentation as applicable.
• Ensure all batch deviations are reported in accordance with Pfizer corporate standards.
• Provide input and support to manufacturing operations teams in the investigation of manufacturing deviations and resolution of discrepancies.
• Conduct cGMP compliance area walk-throughs of Manufacturing Operations as required.
• Ensure all manufacturing related CAPAs are implemented in a timely manner and are effective in support of RFT principles.
• Review and approve all manufacturing related change controls and ensure all changes are reported in accordance with the Pfizer corporate standards.
• Provide support to the investigation of product complaints as required.
• Assist in the creation and maintenance of up to date QA policies, SOP’s and reports.
• Assist in the development of training curricula and records for the QA Operations Group.
• Provide training on Quality Assurance SOP’s as required.
• Participate in cross-functional teams as required.
• Provide consultative support on quality related topics to Manufacturing Operations.
• Participate in the internal audit programme as required.
• Support the introduction of new products including validation campaigns and tech transfer projects.
• Perform and assist with additional duties as may be directed by the QA Ops Lead or QA Senior Manager.

Education/Experience

• Relevant Third Level Qualification or Equivalent (Exceptions may be considered where relevant skills/experience and correct attitude and behaviors exist (this may be supplemented by further education in parallel).
• Previous relevant Quality experience as detailed above in the job responsibilities section, within a QA/QC GMP environment in a Pharma/Biotech company.
• Excellent communication and interpersonal skills.
• An ability to work independently, as well as a member of a team in a dynamic, fast-paced environment.

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Ireland      Manufacturing and Logistics      Quality Assurance      Pfizer