QA Specialist – Pfizer

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Job Description

Quality Assurance Specialist 

Pfizer Grange Castle, Dublin and Pfizer, Newbridge

Both Contract and Permanent roles available. 

Job Responsibilities: 

General 
• 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 

Batch Disposition 
• 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. 

Customer Complaints 
• 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 

Stability 
• 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. 

Metrics/Tracking 
• 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 

Inspection/Audit 
• 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 

Documentation Management 
• 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. 

Quality Agreements 
• Ensure Quality Agreements are in place with all 3rd parties, affiliates and other Pfizer sites 
• Conduct periodic reviews of all Quality Agreement 

Training 
• 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. 


Education/Experience: 
• 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. 

Apply via LinkedIn

Shyni Fernandez

Talent Partner +353 1 614 6053 shyni.fernandez@cpl.ie
  • Salary:Negotiable
  • Location:Grange Castle
  • Type:Contract
  • Category:Science
  • Ref.no:JO-1906-432099_8