LSC have a great contract opportunity for a Documentation Specialist to join a global Biopharmaceutical company in Cork. The facility specializes in the fermentation, purification and sterile filling of biotech products, as well as supporting product development and clinical trials.
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Creating, editing, and formatting of SOPs, Work Instructions, and other documents on the MSD EDMS 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.
- 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.
- Responsible for maintaining the Site Master file for current effective cGMP documents on site.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- 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.
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
Apply via this advert or contact Grainne Hodnett e @0214777329 if you have any more questions about this opportunity!
