LSC have a great contract opportunity for a QA Validation 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.
If you have +5 years’ experience in a cGMP regulated manufacturing environment, and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT – KEY RESPONSIBILITIES:
oProvide quality and project management oversight for review and approval of Qualification and Validation of Facilities, Utilities & Equipment (FUE) activities related to company products.
o Project lifecycle documentation e.g. URS, Commissioning/ Qualification Protocols, GMP Risk Assessments, Design Specifications, Functional Specifications, Installation Qualification, Operational Qualification, Performance Qualification, respective protocols and reports, supporting site discrepancies/deviations, investigation and closure in line with the sites quality standard and site procedures, etc.
o Responsible for delivering the companys Revalidation program (RVE) requirements as per the RVE schedule.
o Coordinate and communicate revalidation activities involving cross-functional, multi-departmental teams including: Engineering, Manufacturing, Process Sciences, Quality Control, Quality Assurance, Regulatory Affairs, etc.
ABOUT YOU – ARE YOUR SKILLS A MATCH?
o Bachelor of Sciences degree, or higher, in a technical discipline (physical, engineering, chemical or biological sciences) is required.
o +5 years’ experience in a cGMP regulated manufacturing environment, with knowledge of Facility, Equipment and Utility validation and Laboratory Systems validation.
o Experience in a number of the following areas would be desirable: Cleaning Validation, SterilisationTemperature Mapping, Packaging Validation, etc. Computer Systems Validation experience would be 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 Ruth Holland at LSC on 021-4777329 if you have any questions about this QA Validation Associate opportunity!