Quality Assurance - In Process QA

About the Company

About the Position

Key Responsibilities

• Support to batch manufacture including line sign-off prior to start of batch manufacture, performing in process checks during batch manufacture.
• Perform routine 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.
• Review of Standard Operation Procedures for manufacturing operations and cleaning.
• Participate in any investigation related to manufacturing.
• Prepare Standard Operating Procedures, investigations, reports and forms as required.
• Perform swab sampling (bioburden and chemical)
• Perform environmental monitoring
• Perform internal / process audits.
• Monitoring of GMP compliance during production activities
• Review of unplanned work orders for production
• Monitor documentation errors and work with personnel to correct documentation, as needed, and develop preventive actions to reduce or eliminate recurrences
• Sampling and inspection activities.
• Issuance of documentation for production – Batch Record, SOPs.

Experience/Requirements

• 2+ years Experience in Pharmaceutical GMP environment preferably with a company accredited with HPRA and FDA
• Third level qualification in relevant area

Remuneration Package

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