LSC have a great contract opportunity for an Operations Compliance Specialist to join a Cork based Biopharmaceutical company. The site manufactures low volume bulk API for Phase III clinical trials, initial product launch and long-term market support. The team on site grow, purify, formulate, and bulk fill mammalian cell culture derived APIs for medicines intended for human use.
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Manage the authoring & drafting of all types of Manufacturing Operations documentation.
- Specifications & associated forms in conjunction with the various departmental subject matter experts (SME)
- Support document updates and manage timelines for cross functional Projects.
- Act as a SME/Superuser on the Controlled Document System to facilitate the processing & approval of documents.
- Organise & Facilitate Document Round Table meetings with cross functional teams as required
- Mange and build Quality Veeva QMS metrics for Manufacturing Operations
- Coach & Train colleagues in Documentation System & GDP queries
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Working knowledge in Regulations, GMP, GDP
- 3+ working within a regulated healthcare industry including a role in capacity of quality and compliance.
- Experience using Veeva is essential
Apply via this advert or contact LSC on 021 4777 329 if you have any more questions about this opportunity!
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!
