The role will have responsibility for escalating high risk issues to management while providing support to the wider organisational team.
The position will also support Global Quality and Compliance projects
The role will have Quality Operations, Quality Systems, Quality Control, Regulatory and QA Validation teams reporting into it.
- Day to day leadership for Quality aspects of the site
- Member of the Site leadership Team which decides and implements strategy and direction.
- Eligible to perform the Qualified Person (Q.P.) role in accordance the legislative requirements within Article 51 of Directive 2001/83/EC and Article 55 of Directive 2001/82/EC3.
- Oversight and governance of the Quality Management System
- Authorisation and Approval of Change Records, Validations and Qualifications.
- Communication with Competent Authorities as and when required.
- Leading preparation for and hosting of regulatory and Corporate Quality inspections.
- Review and approval of all Regulatory Filings.
- Governance of all External and Internal audit programmes and plan, executing and following up on supplier site visits
- Responsible for ongoing inspection readiness program to ensure that Quality System is managed and maintained.
- Responsible for maintaining compliance of licenses
- Lead continuous improvement efforts for projects identified at the suppliers or within the plant.
- Participate actively on cross-functional operational and process improvement teams.
- Seek to identify and execute safety improvements and waste minimization opportunities.
- Support the wider Teva Quality group as required.
- Support scorecard development, maintenance, reporting and action / project development from scorecards.
- Minimum BSc Chemistry / Biological / biotechnology degree or equivalent.
- Qualified Person status is preferable
- Postgraduate qualification an advantage
- Minimum 10 years' experience in a QA or equivalent role
- Extensive experience in cGMP systems, pharmaceutical manufacturing and testing, experience must include role(s) in a manufacturing setting
- Managerial or Supervisory experience required
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.