QA Specialist
Summary: Quality Support to Production and warehouse activities including batch record review, Investigation support, Batch Release support, Documentation review and audits to ensure batches are manufactured in compliance with regulatory requirements, company policy and procedures.
Essential Duties and Responsibilities include, but are not limited to, the following:
• Perform full review of documentation such as Batch records, logbooks, forms, protocols, reports, COAs, etc. generated to support commercial and development batches for accuracy, completeness, and compliance to GMP and procedural requirements.
• Preparation of Document Pack to aid Batch Release e.g. Batch Records, Certificate of Compliance, Retain Sample for Inspection.
• Labelling of batches for release.
• Review of Standard Operation Procedures for manufacturing operations.
• Participate in any investigation related to manufacturing.
• Lead any investigation related to QA Operations including co-ordination of investigation team, identification of root cause, report writing and CAPA monitoring.
• Preparation of Standard Operating Procedures, reports and forms related to QA Operations.
• Perform internal / process audits to monitor GMP compliance during production activities.
• Monitor documentation errors and work with personnel to correct documentation, as needed, and develop preventive actions to reduce or eliminate recurrences.
• Management of retain samples.
• Understanding of equipment qualification, cleaning validation / analytical testing / microbial
• Participate in and provide support for regulatory, customer and/ or corporate audits
• Ensure that relevant procedures and systems are continually evaluated and updated to reflect regulatory changes, thereby maintaining compliance with regulatory requirements.
Education & Experience:
minimum of 3 year experience in Pharmaceutical GMP environment
Accredited with HPRA and FDA or Post Graduate Qualification in Pharmaceutical area
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