Job Title: Documentation Specialist
Detailed Description:
The company has invested €130 million in the last five years to fuel its growth and expansion. This is an exciting time to join the facility as new products are being introduced.
Key Responsibilities:
1. Create, edit, and format SOPs, Work Instructions, and other documents on the MSD EDMS (Veeva Vault) from material supplied by Vaccine IPT SMEs.
2. Liaise with key stakeholders such as Quality, Change Control, SMEs etc. to ensure compliance, correctness, content, and delivery.
3. Lead the tracking and maintaining of project document delivery schedules for the team using Excel.
4. 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.
5. Provide site knowledge and experience in Quality Documentation Systems.
6. Be responsible for the use of the Site Documentation System including Issuance, reconciliation, storage, archiving and retrieval of cGMP documentation to support manufacture & testing of our products.
7. Maintain the Site Master file for current effective cGMP documents on site at Brinny.
8. Utilize knowledge to improve Quality Documentation Systems, solve problems, provide continuous improvement, and execute tasks.
9. Contribute to project teams regarding compliance and lead small projects.
Required Skills:
* 1-5 years' experience as a documentation specialist or equivalent in a pharmaceutical or 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).
* Desirable: Qualification in a biological science subject.
* Desirable: Evidence of Continuous Personal Development.