As the Qualified Person you will be responsible for ensuring that practices at the company are in compliance with cGMP as stated in Directive 2003/94/EC and in the Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2002.
Responsibilities:
1. Ensure practices and products released from the site are in compliance with cGMP as stated in Directive 2003/94/EC and in the Rules and Guidance for Pharmaceutical manufacturers and Distributors 2002.
2. Provide oversight and support improvement of site quality systems and GMP practices.
3. Review and approval of Quality documentation.
4. Work with relevant departments to ensure timely closure of quality actions/ findings.
5. Support investigation of deviations ensuring all product deviations are closed prior to product release.
6. Complete all duties as per relevant local and global procedures.
7. Conduct duties in a safe manner and report all safety issues or concerns.
8. Maintain work area to good housekeeping standards.
9. Lead quality improvement projects.
10. Mentor QA Specialists.
11. Actively contribute to continuous improvement initiatives.
Requirements:
1. Third level qualifications (degree in science or related discipline preferred) appropriate for eligibility for Qualified Person status.
2. Minimum of 5 years’ experience in the pharmaceutical industry in a QA role.
Contact:
If you would like to learn more about the vacancy, apply now, or contact Stephen O'Brien at Stephen@elusav.com or +3536959993.
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