Operations Compliance Specialist

2 weeks ago


Cork, Cork, Ireland LSC, Life Science Consultants Full time

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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
  • 2+ working within a regulated healthcare industry including a role in capacity of quality and compliance.
  • Experience using Veeva is essential

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 Sarina Abdulha at LSC on 021-4777329 if you have any more questions about this opportunity

Seniority level
  • Seniority levelMid-Senior level
Employment type
  • Employment typeContract
Job function
  • Job functionWriting/Editing
  • IndustriesPharmaceutical Manufacturing

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