LSC have a great contract opportunity for a QA Specialist 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.
If you have minimum 3 years’ relevant experience in a cGMP regulated manufacturing environment, with exhibited knowledge and proficiency in Quality Assurance and Compliance and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT – KEY RESPONSIBILITIES:
o Prepare the site for GMP operations by supporting cross functional GMP readiness initiatives
o Review and Approval of electronic and paper production batch record
o Daily presence and support on the manufacturing floor
o Release of Raw Materials for production
o Support the Technology Transfer of a new product into the site including raw material and supplier qualification
o Support quality systems on site.
o Review and approve new or updates to standard operating procedures (SOPs) and master batch records.
o Review and approve Trackwise deviation and investigation reports to ensure that root causes have been identified and appropriate corrective actions have been implemented.
o Review and approve Change Control documents
o Assist with regulatory inspections.
ABOUT YOU – ARE YOUR SKILLS A MATCH?
o Bachelor of Sciences (BSc) degree, or equivalent, in a technical discipline (physical, engineering, chemical or biological sciences, pharmacy) is required.
o Experience in supporting manufacturing operations, batch record review and deviation/CAPA 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!
To apply, submit your CV via this advert or contact Ciaran Murphy at LSC on 021-4777329 if you have anymore questions about this QA Specialist opportunity!