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.
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.
- Generate Reports/Metrics & analyze trends as required including but not limited to:
- Veeva QMS reports, Doc Tracker Lookaheads, ASI/AIC metrics, Logbook Metrics,
- Doc Tracker Metrics, RFT Metrics.
- Perform Logbook Training, review, and trending of all closed logbooks, identifying issues and managing timely archiving.
- Train and perform Area Self Inspections & Generate ASI schedule.
- Train Manufacturing colleagues in GDP/GMP
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- 2+ years' experience in technical writing and compliance
- Proficient in data analytics, data visualization
- Working knowledge in Regulations, GMP, GDP
- 2+ working within a regulated healthcare industry including a role in capacity of quality and compliance.
- Strong verbal, written and oral communication skills.
- Able to work independently and be flexible to changing priorities
Call Kathy Gillen LSC on 021 4781212 to discuss in detail or apply directly via this advert.
Applicants will need to hold a Stamp 1G/Stamp 4 visa to apply and LSC do not provide work permit sponsorship.
