Quality Assurance Specialist
Pfizer Grange Castle, Dublin and Pfizer, Newbridge
• Ensure compliance with cGMP, corporate standards/Pfizer Quality System (PQS), site policies/procedures, regulatory requirements and industry standards.
• Partner closely with customers and stake-holders to understand and deliver on all records within timelines and escalate when necessary.
• Participate in cross functional teams as required to provide consultative support on quality related issues. Provides support with investigations and resolution of discrepancies e.g. Method 1 etc. Assures completeness in terms of root cause, action taken, and CAPA.
• Authors, tracks, review for adequacy: procedures, investigations, commitments (Regulatory Agency, investigation, audit, etc), change controls, forms, logbooks, protocols and reports etc.
Annual Product Record Reviews (APQRs):
• Facilitate creating and maintaining the schedule for completion of APQRs
• Work with areas / subject matter experts to ensure timely evaluation, review and approval of PRR chapters and compilation of final report.
• Review, compile and maintain all procedures and supporting documentation associated with the PRR process
• Ensure that operational instructional documentation (SOPs and batch records) are up to date, compliant, and supports efficient production.
• Perform completion of batch disposition packs including review of batch records and event/investigation reporting within required timelines. This includes identification of discrepancies and ensuring all steps have been performed and verified, that all limits and specifications have been met.
• Generate and provide Board of Health protocols and support related market release activities
• Work with site QPs to ensure timely issue resolution to final disposition.
Changes/New Projects/Periodic Evaluations
• Support the introduction of new products.
• Provide guidance to cross-functional, multi-departmental project teams on quality regulations for Commissioning/Qualification/Verification strategy and approach.
• To review and approve qualification/verification protocols/reports, procedures, specifications, validation deviations and project validation/plans as required.
• Review/approval of technology documentation including cleaning and process validation plans, protocols and reports.
• Support the timely release of equipment, utilities, facilities and computer systems following execution of test protocols.
• Key member of Quality Risk Management and Operational Excellence to improve efficiencies and to promote continuous improvement. Identify and Implement Continuous Improvement opportunities.
• Ensure that change controls and automation change requests are compliant with applicable procedures and maintain the validated state.
• Co-ordinate and Assist with the analysis and investigation of customer complaints
• Utilize both Corporate and local systems for management, investigation and reporting of customer complaints
• Ensure all complaints are closed within specified timeframes
• Facilitate creating and maintaining the schedule for completion of Annual Stability Program.
• Initiates, authors or assists in out of specification investigations
• Key role in participating in Stability Review Board (SRB) process.
• Manage the Reserve/Retain samples management program
Raw Material/Component/CPA Compliance:
• Ensure site BSE/TSE status is maintained current
• Oversight of vendor investigations.
• Approval of GMP documentation in support of raw material testing
• Provide oversight to ’use of material at risk’ process.
• Packaging Component Quality
• Quality oversight on vendor performance management and vendor certification program for packaging component suppliers
Supplier Quality Management:
• Preparation of Supplier Quality Agreements in conjunction with supplier quality management teams.
• Liaising with business and purchasing as part of the supplier sourcing and assessment process
• Preparation / approval of supplier qualification packs
• Maintenance of supplier status on SMS
• Monitoring / reporting on supplier qualification metrics to meet re-evaluation requirements, including escalation of supplier quality issues / adverse audit findings
• Liaising with corporate to meet all requirements for Legacy plans / ongoing system maintenance
• Assist in the generation of the Supplier Audit schedule
• Review Supplier audit reports
• Act in an advisory capacity for all supplier audit related queries.
• Maintain tracking system for batch/document review status. Support the use of visual management to track and trend activities.
• Support trending and compilation of investigation/system reports, customer complaints and audit listings in a timely manner.
• Provide updates/metrics to the Grange Castle SQRT as required
• Ensure inspection readiness in work completed.
• Carryout cGMP compliance area walk-throughs of Manufacturing Operations as required ensuring site is always audit ready.
• Support and participate in site self-inspections, internal audits, board of health audits and third party audits.
• Review and approve internal audit reports
• Conduct audits as per internal audit schedule
• Conduct Supplier audits as required.
• Liaise with MSQA to ensure all suppliers are audited as per the defined frequency
• Manage and maintain the Documentation System. Management of site archive, storage, retrieval and destruction processes.
• Act in an advisory capacity on Documentation issues to site personnel.
• Ensure Quality Agreements are in place with all 3rd parties, affiliates and other Pfizer sites
• Conduct periodic reviews of all Quality Agreement
• Assist in the development of training curricula and records for the QA Operations Group.
• Assist in the creation and maintenance of up to date QA policies, SOP’s and reports.
• Provide training on Quality Assurance SOP’s as required.
• To stay current with all personal training requirements.
Compliance Network Member (CNM):
• Co-ordination of site documentation to support regulatory filing activities
• Review of regulatory documentation.
• Relevant Third Level Qualification or Equivalent
• 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.