QP Manager

ABOUT THE ROLE

As the Manager Qualified Person, you will ensure that all products released for commercial use comply with the Marketing Authorisation and are manufactured in line with GMP requirements as set out in Directive 2003/94/EC.

Key Responsibilities

• Ensure all manufacturing, testing, and packaging activities adhere to cGMP, cGLP, regulatory, and licence requirements.
• Oversee and manage batch documentation, ensuring completion and approval by appropriately trained personnel.
• Review and release batches in line with shipment schedules, ensuring full regulatory compliance.
• Identify and recommend process improvements aligned with the organisation’s Continuous Improvement initiatives.
• Define batch investigation requirements and assign responsibilities.
• Release batches according to planned shipment dates where feasible.
• Ensure key manufacturing and testing processes are fully validated.
• Confirm all necessary checks, tests, and production record reviews have been completed.
• Ensure planned changes or deviations are reported through the established system prior to release; escalate changes requiring authority approval (e.g., HPRA) when applicable.
• Initiate or complete any required additional sampling, inspections, testing, or checks related to planned changes or deviations.

Experience & Qualifications

• Qualified Pharmacist or holder of a Diploma in Pharmaceutical Manufacturing Technology (or equivalent), meeting Qualified Person requirements under E.C. Directive 2001/83.
• Proven experience in the pharmaceutical sector in a senior QA, QC, or compliance-focused role.
• Strong knowledge of applicable regulations and regulatory information sources.
• Skilled in report writing and documentation review.
• High attention to detail and consistency in reviewing processes, tasks, and quality records.
• Ability to analyse information, identify key issues, compare data sources, and understand cause-effect relationships.
• Understanding of standard operational procedures, policies, and systems (e.g., ERP platforms such as SAP).
• Authority and experience in approving/rejecting product batches.
• Demonstrated capability in reviewing and approving investigations, including deviations and out-of-specification results, prior to batch release.
• Experience acting as a QP for the release of product categories within their area of knowledge and expertise.
• Experience supporting or coordinating recall decision-making processes.