Quality, Science, Pharmaceutical & Food
PE Global View all jobs
- Co Meath
- Permanent
- Full-time
- Liaise daily with cross-functional teams to collaboratively and actively to address compliance issues in a timely manner.
- Participate in investigations and risk assessments related to deviations/ complaints and changes, ensuring appropriate actions are implemented to meet deadlines.
- Provide QA review and approval of Change Controls, Deviations/CAPAs, SOPs and related documentation for compliance to GMP and site requirements.
- Provide QA oversight to the qualification/validation, technical transfers, regulatory approvals, laboratory operations and commercial operations.
- Perform material disposition of incoming material to the site.
- Assist in the development of training curricula and records for the QA Operations group, providing SME training on Quality Assurance SOPs as required.
- Support an environment of continuous improvement by identifying and implementing efficiencies and quality improvements.
- Work collaboratively to foster strong relationships with management and colleagues and to drive a safe and compliant culture on site.
- Participate in and support risk management activities in line with relevant guidance and best industry practice.
- Ensure the escalation of compliance risks to management in a timely manner.
- Keep informed of the latest developments from regulatory authorities in relation to quality compliance.
- Support cross functional departments by responding to quickly to unplanned events and technical issues.
- Perform real time exception review by maintaining on the floor operations support during manufacturing.
- Support the site’s walk-through/ GEMBA process as assigned.
- Possess knowledge of contamination control processes and assist in identifying/ mitigating contamination risks to ensure optimal product quality and compliance with regulatory standards.
- Degree qualification (Science/Quality/Technical).
- 4-7 years’ experience, ideally in Quality Assurance, Quality Control or Technical Operations within the Biological and/or pharmaceutical industry.
- Experience with PAS-X, SAP and Veeva is desirable.
- Project Manager capability with significant understanding of Operations and/or Laboratories.
- Demonstrated experience in QRM, Investigations, problem solving as a Quality SME.
- Strong written and verbal communication skills.
- Ability to think logically and be proactive under pressure.
- Ability to work as part of a team and on own initiative in a constructive manner.
- Strong attention to detail and precision in preparing and reviewing GMP documentation.
- Demonstrated knowledge and application of industrial regulations including those of FDA, HPRA, EMEA and other authorities related to Biologics and/or Pharmaceuticals.
- Experience in direct interactions with regulatory agencies during site inspections.