QA Specialist – Pfizer – Ringaskiddy

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Job Description

CPL, in partnership with our client Pfizer, require QA Specialists to join their API plant at Ringaskiddy, Cork.

The QA Specialist will be committed to continuous improvement, leading initiatives and working with members of the Value Stream, Operations, Engineering, Supply Chain and Quality Operations to assure high quality standards that support the Ringaskiddy site strategy. 

Your responsibilities:
  • Review and approval of master batch records and executed batch records to assure compliance with regulatory standards and regulatory filing. 
  • Disposition of intermediates and API including batch record review. 
  • Review and approval of deviations, change controls, SOPs, out of compliances, laboratory investigations and Post MIs. 
  • Lead /support process, equipment and cleaning validation. 
  • Ensure all quality systems are implemented/executed in compliance with ICH Q7 and PQS. 
  • Lead periodic audits and reviews of manufacturing operations and quality systems to ensure compliance with cGMPs and other regulatory requirements. 
  • Maintain internal audit schedule. 
  • Revising SOPs and providing training as SME where required. 
  • Lead/support root cause analysis investigations including Pfizer Human Performance (PHP) investigations and quality risk assessments to ensure effective investigations to identify and implement CAPAs within the agreed timeframe 
  • Execute/support projects to drive quality excellence (using benchmarking as required) 
  • Batch release (supply): Responsible for batch release lead time enabling on time production and shipping 

Your experience and requirements:
  • BSc in Chemistry or equivalent. 
  • Thorough knowledge of GMP’s and regulatory expectations for manufacturing of APIs 
  • 3+ years of experience working in the pharmaceutical manufacturing industry, preferably in Quality or a related Technical function. 
Initial 11 month contract with a view to an extension.
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Cormac O'Brien

  • Salary:Negotiable
  • Location:Ringaskiddy
  • Type:Contract
  • Category:Science