LSC have a great contract opportunity for a Compliance Specialist - Technical Operations to join an innovative and rapidly growing Biopharmaceutical company in Limerick. The facility is responsible for the production, packaging, labelling and delivery of biopharmaceutical medicines for global markets. The company currently markets medicines for various diseases and has a rich pipeline of products.
If you have 2+ years' experience in operations or manufacturing in a GMP pharmaceutical or biologics facility and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Completes deviation investigations and report writing for department issues of non-compliance. Ensures CAPAs are identified as appropriate and are implemented as planned.
- Provides support, information, and assistance to the department on change controls, risk assessments, impact statements and corrective/prevention action plans.
- Review and approval of preventative maintenance records/work orders (corrective and scheduled) on the CMMS system to assess for compliance with established standard operating procedures.
- Provide periodic review of department documentation and records such as Periodic Evaluation Reports (PER), Logbooks, Life Cycle Documents and Engineering Documentation, etc. to assess for compliance with established quality standards, policies, and procedures.
- Maintains knowledge of current good manufacturing practices (cGMPs) and execution of any other GMP compliance related activities as required.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Bachelor's degree in a scientific/technical discipline
- Experience in current good manufacturing practices (cGMPs) and execution of GMP compliance related activities preferably in Engineering, Automation or Facilities.
- Ability to apply cGMP regulations and guidelines to all aspects of Technical Operations activities.
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 Peter Cronin at 021 4777321 if you have any more questions about this opportunity!