LSC have a great contract opportunity for a Compliance Specialist 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.
KEY RESPONSIBILITIES:
- Completes investigations of technical 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.
- 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.
- 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.
- 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.
- Review and approval of preventative maintenance records/work orders (corrective and scheduled) on the CMMS system 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?
- Basic knowledge of regulatory compliance inclusive of cGMP, FDA regulations, familiarity with ICH guidelines and EU regulations.
- Deviation investigation experience is essential
- Proficient in Excel, PowerPoint, Visio, Word, etc. In addition to experience working within shared work environments.
- Strong interpersonal, written, presentation, communication skills with the ability to engage with a diverse range of individuals across all levels of the organization.
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 Grainne Hodnett at (021) 477 7329 if you have any more questions about this opportunity!
