Join to apply for the Operations Compliance Specialist role at LSC, Life Science Consultants.
LSC, Life Science Consultants provided pay range
This range is provided by LSC, Life Science Consultants. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range
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!
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Quality Assurance
Industries
Pharmaceutical Manufacturing
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