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 a Bachelor of Sciences degree, or higher, in a technical discipline (physical, engineering, chemical or biological sciences) and ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Provide project management oversight for validation activities related to products and Facilities, Utilities, Equipment (FUE), Packaging, CSV (Computer Systems Validation) CV (Cleaning Validation) and CTE (Controlled Temperature Environment) operations.
- Execute (protocol generation, execution, and final package preparation) validation activities related to the implementation of Facilities, Utilities, Equipment (FUE), Packaging, CSV (Computer Systems Validation) CV (Cleaning Validation) and CTE (Controlled Temperature Environment) 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 developed or manufactured, validation techniques/approaches and systems utilized.
- Lead and represent Validation in multi-departmental meetings & project teams.
- Identifies and implements improvements to the QA Validation systems.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Minimum of 2 - 3 years' experience working in C&Q in equipment or utility qualification and be familiar with ISPE Baseline C&Q guideline.
- Organizational and management skills to coordinate multi-discipline project groups
- Ability to speak, present data, and defend approaches in front of audiences and inspectors.
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 Sarah Ninan at LSC on 021-4777329 if you have any more questions about this opportunity!