Documentation Specialist - 12 Months + Possible Extensions - Cork
The site has received €130 million in investment over the last five years to continue the growth and expansion of the facility; with new products coming to the site, it is an exciting time to join the team.
Bring energy, knowledge, innovation, and leadership to carry out the following:
1. Creating, editing, and formatting of SOPs, Work Instructions, and other documents on the MSD EDMS (Veeva Vault) from material supplied by the Vaccine IPT SMEs.
2. Liaison with key stakeholders e.g., Quality, Change Control, SMEs etc. to ensure compliance, correctness, content, and delivery.
3. Lead the tracking and maintaining of the 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. Provides to the site knowledge and experience in Quality Documentation Systems.
6. 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.
7. Responsible for maintaining the Site Master file for current effective cGMP documents on site at Brinny.
8. Uses knowledge to improve Quality Documentation Systems, solve problems, provide continuous improvement, and execute tasks.
9. Provides compliance contribution to project teams and leads small projects.
What skills you will need:
In order to excel in this role, you will need to have:
1. 1-5 years’ experience as a documentation specialist or equivalent in a pharmaceutical or a highly regulated environment.
2. Experience in maintaining and updating excel schedules and trackers for small projects.
3. Advanced PC skills such as Excel, Word, PowerPoint.
4. Stakeholder management of multi decision makers, colleagues, peers, and cross functional teams.
5. Knowledge and experience of GMP and GDP in a pharmaceutical environment.
6. Desirable: Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation (e.g., Manufacturing, Quality, Engineering, Tech Services etc).
7. Desirable: Qualification in a biological science subject.
8. Desirable: Evidence of Continuous Personal Development.
If this role is of interest to you, please apply now!
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