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.
Key Responsibilities:
* Creating, editing, and formatting SOPs, Work Instructions, and other documents on the MSD EDMS (Veeva Vault) from material supplied by the Vaccine IPT SMEs.
* Liaison with key stakeholders e.g., Quality, Change Control, SMEs etc. to ensure compliance, correctness, content, and delivery.
* Leading the tracking and maintaining of the project document delivery schedules for the team (using Excel).
* Engaging 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.
* Providing knowledge and experience in Quality Documentation Systems.
* Responsible for using the Site Documentation System including issuance, reconciliation, storage, archiving, and retrieval of cGMP documentation to support the manufacture and testing of our products.
* Responsible for maintaining the Site Master file for current effective cGMP documents on site at Brinny.
* Using knowledge to improve Quality Documentation Systems, solve problems, provide continuous improvement, and execute tasks.
* Providing compliance contribution to project teams and leading 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.