Quality Assurance Role Dublin

Inspection Readiness Senior Specialist, Compliance

  • Posted Mar 5, 2021
  • Dublin
  • Contract
  • VAC-18948

LSC have an exciting contract opportunity for a Inspection Readiness Senior Specialist, Compliance to join a leading Biotech company based in Dublin.

If you have a minimum of 8 years' experience in a similar Compliance-related role in the Biopharmceutical industry and are ready for your next challenge, this could be the perfect project for you!

ABOUT THE PROJECT - KEY RESPONSIBILITIES:
o Support the implementation of the Inspection Readiness Program on-site.
o Support Compliance direction for the site by ensuring adherence to divisional policies and guidelines as well as applicable Regulatory Requirements.
o Lead proactive evaluation of site compliance against emerging regulatory trends.
o Be an advocate of continuous improvement in the Quality Management Systems.
o Initiate and maintain Quality related metrics related to the Site Inspection Readiness program, ensuring effective communication and follow up of same.
o Lead and perform internal audits (facility, system and walkthrough) in addition to supporting management of the internal audit schedule at the site.

ABOUT YOU - ARE YOUR SKILLS A MATCH?
o Bachelor's degree (or higher) in Chemistry, Biology, Microbiology, Engineering or in a relevant discipline, the successful candidate will also ideally have a proven track record in delivering excellence.
o Must have at least 3 years' experience in delivering Inspection Readiness Programs and Internal Audit programs in a pharma/biotech regulated environment.
o Experience working in a drug substance manufacturing environment is highly desirable.

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 Katie Brown at LSC on 021-4777329 if you have anymore questions about this Inspection Readiness Senior Specialist, Compliance opportunity!

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