- This role will be responsible for supporting the Quality Systems Department in the management of the site GMP documentation, and in supporting the Quality Assurance functions in various administrative duties.
- Ensure that objectives are effectively achieved, consistent with the company requirements to ensure compliance, safety and reliable supply to our customers
Core Duties and Responsibilities:
- Responsible for the control, operation and maintenance of the site Central Documentation Control system
- Be a document system expert; this will include document generation, review, approval and document system work flow expedition e.g. SOP’s, Work Instructions, Reports
- Format, write, deliver and review necessary documentation in line with the standard approval process, and facilitate others to do so.
- Support site activities through documentation generation, filing, tracking, auditing and maintenance of associated databases.
- Maintain the site archiving area, logging in new documents and logging out documents as requested following site procedures and practices
- Use standard systems including MS Word, Excel, PowerPoint, Outlook, SAP and various company and industry specific software such as document tracking, work order entry/tracking, procurement, manufacturing entry/reporting, etc.
- General audit preparation of documentation for audits (i.e. FDA, IMB, Corporate, Customer, etc)
- Presentation, compilation and review of data as directed
Minimum Qualifications and Experience:
- 2+ years experience of working in a similar Quality Assurance related role in the Pharmaceutical Industry
- Supervisory experience preferable
- Knowledge of EU/US quality related pharmaceutical regulations
- Degree in Science or related discipline preferable
If you would like to discuss this vacancy or to discuss your career and other job opportunities in confidence, contact us:
Please note, we do not require agency assistance with this role.