LSC have a great contract opportunity for Inspection Readiness Associate 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:
- Generate Reports/Metrics & analyse trends as required including but not limited to:
- EQMS (Self inspection responses, internal audit responses, Regulatory inspection responses)
- Self-inspection/ internal audit/ Regulatory inspection findings
- Self-inspection schedule adherence metrics
- Champion site compliance & Quality culture
- Collaborate with Global colleagues (as required) including but not limited to: Global Quality Systems, Global Compliance & Ethics, GxP compliance, Global Supplier Quality, Global Complaints management.
- Be proactive & collaborative in troubleshooting & resolving issues with documentation, training & systems partnering with all departments across the site.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- BA/BS degree in chemical engineering/chemistry/life sciences; process engineering or validation.
- At least 4 years of experience in GMP site operations.
- Interface with cross-functional teams in a Compliance context
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 LSC on 021-4777329 if you have any more questions about this opportunity!