LSC have a great contract opportunity for a QA Validation Associate to join a Cork based Biopharmaceutical company.
If you have 3+ years' CQV experience in a cGMP regulated manufacturing environment, with exhibited knowledge in any of the following in HVAC, 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:
- Provide project management oversight for validation activities related to the companies 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 by the company, validation techniques/approaches and systems utilized at the company.
- 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?
- Bachelor of Sciences degree, or higher, in a technical discipline (physical, engineering, chemical or biological sciences) is required.
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 Ellen Farley at LSC on 021-4777329 if you have anymore questions about this QA Validation Associate opportunity!