QA Operation Specialist

Role Description

CPL in conjunction with Pfizer is looking for an experienced QA Operations Specialist for the Biotech faciltiy in Grange Castle, Dublin. 

Job Purpose: 

Responsibility for carrying out tasks pertaining to compliance and product quality. The QA specialist will partner with relevant departments to ensure that key quality systems/metrics are operated and maintained in a compliant manner. 

 

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 
  • Liaise with Corporate SMEs and site teams to enhance the site quality systems from a compliance and efficiency stand-point.

 

Network

  • Participate in forums required to support the operation of Quality Systems / Process 
  • Actively support Biotech Communities of Practice (COP) and Common Interest Groups (CIGs) as required.
  • Co-ordinate and participate in the change control/ BCRB process for products manufactured at PGS.

 

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)

  • Responsible for working with the GCMC organization in ensuring Marketing Authorisation (MA) Compliance for products released from the Grange Castle site. 
  • Provide Technical direction and guidance on regulatory impact of changes introduced on site through the site’s change management process. 
  • Co-ordination of BOH requests, commitments and declarations. 
  • Co-ordination of site documentation to support regulatory filing activities 
  • Review of regulatory documentation

 

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.

Interested candidates, please send your CV to Shyni.Fernandez@cpl.ie or contact directly at 016146053.

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