LSC have a great contract opportunity for a Compliance Specialist – Technical Operations to join a innovative and rapidly growing Biopharmaceutical company in Limerick.
If you have minimum of 3+ years experience working in a cGMP environment and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT – KEY RESPONSIBILITIES:
o Acts as a liaison between Technical Operations and onsite quality and regulatory groups, as well as other departments across the company, with respect to all quality instances and compliance support.
o Initiation, coordination, root cause analysis and authoring of Technical deviation investigations on the quality management system for NOEs (low impact deviations), EOEs (medium to high impact deviations) and DNFs (high impact deviations) for department issues of non-compliance. Ensures CAPAs are identified as appropriate and are implemented as planned; in addition, ensures CAPAs have the intended effectiveness.
o Provides support, information, and assistance to individuals, groups and management with the initiation, authorship, review, submission, and follow-up/completion of documents such as Change Controls, risk assessments, impact statements and corrective/prevention action plans.
o Reviewing and maintaining procedures, polices and other instructional documents with a focus on continuous improvement.
o Provide periodic review of department documentation and records such as Periodic Evaluation Reports (PER), logbooks, Life Cycle Documents and Engineering Documetation, etc. to assess for compliance with established quality standards, policies and procedures.
ABOUT YOU – ARE YOUR SKILLS A MATCH?
o Primary degree in Science/Engineering discipline
o Knowledge of Electronic Data Management Systems is an advantage.
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!
To apply, submit your CV via this advert or contact Aaron Kingston at LSC on 021-4777329 if you have anymore questions about this Compliance Specialist – Technical Operations opportunity!