A Quality Documentation Specialist is required for a biopharmaceutical company in West Cork. The incumbent will provide documentation (creating, formatting, tracking of SOPs, Work Instructions etc in the EDMS – Electronic Document Management Systems) support to the operations team.
- Creating, editing, and formatting of SOPs, Work Instructions, and other documents on the EDMS from material supplied by the Vaccine operations SMEs.
- Liaison with key stakeholders e.g., Quality, Change Control, SMEs etc. to ensure compliance, correctness, content, and delivery.
- Lead the tracking and maintaining of the project document delivery schedules for the team (using Excel).
- Engage with Change Control and the wider project team to ensure documents are prepared and updated in time for different stages of C&Q execution and production.
- Provides to the site knowledge and experience in Quality Documentation Systems.
- Responsible for use of the Site Documentation System including Issuance, reconciliation, storage, archiving and retrieval of cGMP documentation to support the manufacture & testing of our products.
- Responsible for maintaining the Site Master file for current effective cGMP documents on site.
- Uses knowledge to improve Quality Documentation Systems, solve problems, provide continuous improvement, and execute tasks.
- Provides compliance contribution to project teams and leads small projects.
- Makes decisions within guidelines and policies which impact own priorities and allocation of time to meet deadlines.
- Part-take in cross-functional problem-solving teams for troubleshooting and investigations within Vaccines operations.
- Ensure compliance with site EHS policy, cGMP and other business regulations and support Technical operations input to risk assessments, audits, regulatory inspections, and incident investigations.
- Ensure the highest Quality, Compliance and Safety standards by participating and complying with our Manufacturing Division Quality Management System (QMS) requirements, including ownership, as relevant.
Qualifications & Experience:
- 3-5 years’ experience as a documentation specialist or equivalent in a pharmaceutical or a highly regulated environment.
- Experience in maintaining and updating excel schedules and trackers for small projects.
- Advanced PC skills such as Excel, Word, PowerPoint.
- Stakeholder management of multi decision makers, colleagues, peers, and cross functional teams.
- Knowledge and experience of GMP and GDP in a pharmaceutical environment.
- Desirable: Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation (e.g., Manufacturing, Quality, Engineering, Tech Services etc).
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