▷ [Urgent] QA CQV Specialist

4 weeks ago

Dublin, Ireland Tandem Project Management Ltd. Full time

Summary

Our client, based in Louth, has an opportunity for a QA CQV Specialist to join their team. This role is responsible for providing quality oversight of all validation and qualification activities, ensuring compliance with current regulatory requirements, cGMP, and company SOPs. The position covers validation activities for facilities, utilities, equipment, computerised systems, cleaning, processes, storage areas, controlled temperature units (CTUs), and shipping. The successful candidate will also support commissioning, qualification, and validation (CQV) activities associated with the site start-up project and help ensure a smooth transition from project phase to routine operations.

Responsibilities

- Ensure quality oversight of the qualification and validation activities of all facilities, utilities, equipment, computerised systems, cleaning processes, manufacturing processes, storage areas, controlled temperature units (CTUs), and shipping processes.

- Review and approve validation documentation and associated data, including plans, URSs, quality risk assessments, protocols, and reports, to ensure compliance with SOPs, specifications, and applicable acceptance criteria.

- Provide QA oversight for all deviations, investigations, and change evaluations that occur during qualification and validation activities, ensuring compliance with SOPs and cGMP requirements.

- Review SOPs related to qualification and validation activities.

- Support regulatory inspections and client audits.

- Provide QA validation expertise to maintain the validated status of the facility.

- Maintain a strong understanding of cGMP regulations and guidance related to validation and qualification of facilities, utilities, equipment, computerised systems, cleaning, manufacturing processes, storage areas, CTUs, and shipping processes.

- Coordinate QA validation activities to ensure schedule adherence and on‑time delivery of project milestones.

- Support performance management, recruitment, and training activities within the QA validation function as required.

- Contribute to continuous improvement of validation and QA systems.

Qualifications & Experience

- Sc or B.Eng in a Scientific or Engineering discipline (e.g. Biochemistry, Chemistry, Engineering).

- 4 to 5 years’ experience in Quality Engineering, Quality Assurance, or Quality Validation within a biologics, pharmaceutical, or medical device manufacturing environment regulated by FDA/EU guidelines.

- Strong understanding of validation requirements for a cGMP manufacturing facility.

- Excellent knowledge of GxP regulations applicable to biologics manufacturing (EU-GMP, FDA, ISO) and relevant industry standards (GAMP, ISPE, ISO, ASME, BPE).

- Experience in troubleshooting and problem-solving using formal root cause analysis methods and tools (e.g. Ishikawa diagrams, FMEA).

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