QA Operations Specialist

Tandem Project Management Ltd.

Dunboyne, County Meath, Ireland

Summary:

A QA Operations Specialist is required for a biopharmaceutical in Dunboyne. The QA Operations Specialist role involves supporting the operational activities, technical transfers, regulatory approvals and commercial operations on site.

Responsibilities:
• Reviews and approves batch records, discrepancy reporting, investigations and CAPAs associated with all areas of Manufacturing operations.
• Responsible for supporting execution of an effective Quality system and accountable for quality oversight of quality management systems (CAPAs, Change Controls, Deviations Batch Documentation Review).
• QA oversight to the qualification/validation, technical transfers, regulatory approvals and commercial operations at the facility.
• Review/Approval of validation/qualification/verification protocols and reports associated with new product or material entry.
• Helps maintain site practices and procedures related to facility start-up, instrument qualification, usage, technology transfer... More Detail

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