The company has a number of programmes in clinical development that focuses on diseases related to the eye, central nervous system and others. They operate a state-of-the-art GMP manufacturing facility in London and Ireland.
Key Responsibilities:
- User Management
- Document Review, Approval & Release
- Reviewing Batch documentation
- Setup and maintain training courses and curriculum
- Workflow Management
- User Support
- eQMS and Document support during Regulatory, Competent authority and Third-Party audits.
- Issuance of Batch Manufacturing Records and Batch Numbers.
- Hard Copy Document Retention and Archiving.
- Organise and manage QA Document Control visibility and activities.
- Author and maintain procedural documents related to management of documents within the QMS
- Maintain documentation held externally from the QMS, including document issue, return and archiving as required
- Support QMS projects, including partaking in computer system validation activities where required
- Develop and deliver training related to the QMS and any other role related training as required
- Support Periodic System Reviews as required
- Provide Key Performance Indicator Reports for departments as required
Experience:
The successful candidate will have a strong scientific/ technical background with experience gained in Pharmaceutical or Biotech environment, Quality Assurance environment in document control paired with knowledge of GxP and GMP. Experience of using eQMS would be desirable to your application. In addition, you will need a strong and enthusiastic work ethic, excellent communication skills and attention to detail and enjoy a closely-knit team environment.