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