LSC have a great contract opportunity for 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.
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Provide project management oversight for FUE activities related to products and facilities, utilities, equipment (FUE).
- Developing validation plans for specific system implementation projects.
- Performing and reviewing (project lifecycle documentation (URS, RA, Commissioning, Qualification Protocols)) validation activities related to the implementation of facilities, utilities, equipment changes while exercising judgment within broadly defined procedures and practices to establish approval criteria, and identify and implement solutions.
- Establish Site Validation Policies, through development, generation and implementation of validation master plans, guideline documents and SOP's.
- Maintain current knowledge of industry standards and regulatory requirements for products validation techniques/approaches and systems utilized
- Lead and represent Validation in multi-departmental meetings & project teams.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Minimum 2 year's experience in either the Cleaning, Steaming, Analytical or Equipment validation disciplines.
- Understanding and familiarity with FDA & European regulatory requirements, guidelines, and recommendations for equipment validation expectations.
- Proficiency with technical summary report generation required, with exceptional organizational, spelling, grammar, and typing skills preferred.
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!
