QA Validation Lead

COLLINS MCNICHOLAS RECRUITMENT

SLIGO

QA Validation Lead. QA Validation Lead role at an expandingmulti-million dollar state of the art biologics facility. The Validation Team Lead will be responsible for coordinating and implementing the site Validation Program. Key Responsibilities: Ensure all Computerized systems are qualified in compliance with Data Integrity policies and regulatory requirements. Co-ordination / direction and active participation in the validation of site equipment, facilities, utilities, processes and software in compliance with AbbVie policies, FDA, European cGMP and GAMP standards. Generation/maintenance of the Validation Master Plans. Generation/maintenance of Project Validation Plans. Generation of validation protocols and final reports to cGMP standard. Review / approval of all protocols and final reports. Management of validation change control process. Key Requirements. 3rd level qualification in engineering or scientific discipline. A minimum of 5 years experience in a cGMP regulated environment, with validation activities demonstrated successfully. People Management experience is desirable. ****************************************************************************** For a confidential discussion and more information on the role, please contact Davin Ferguson on 0719140251 or emaildavin.ferguson@collinsmcnicholas.ie. For more information on our Recruitment and HR Services, and to see a full list of our available jobs across Ireland, please visit our website at www.collinsmcnicholas.ie. Follow us on LinkedIn and connect with our consultants to discuss all the latest jobs!.

1685 days ago