LSC have a great contract opportunity for a QA Validation Associate to join a Cork based Biopharmaceutical company.
If you have 3+ years' experience in a cGMP regulated manufacturing environment, with exhibited knowledge and a high level of proficiency in Facilities, Utilities, Equipment (FUE), Packaging, CSV (Computer Systems Validation) CV (Cleaning Validation) and CTE (Controlled Temperature Environment) disciplines and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
o Provide project management oversight for validation activities related to company products and Facilities, Utilities, Equipment (FUE), Packaging, CSV (Computer Systems Validation) CV (Cleaning Validation) and CTE (Controlled Temperature Environment) operations.
o Management, Development, Execution and reporting as part of the Revalidation Evaluation (RVE), Periodic Review Reporting (PRR) and Continued Process Validation (CPV) programs are key deliverables for the Business Sustainability team.
o 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.
o Establish Site Validation Policies, through development, generation and implementation of validation master plans, guideline documents and SOP's.
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 Understanding and familiarity with FDA & European regulatory requirements, guidelines, and recommendations for Facilities, Utilities, Equipment (FUE), Packaging, CSV (Computer Systems Validation) CV (Cleaning Validation) and CTE (Controlled Temperature Environment).
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 Conor Dolan at LSC on 021-4777329 if you have anymore questions about this QA Validation Associate opportunity!
