Manager - QA Validation

CareerWise Recruitment

Limerick

A Snr Manager / Manager QA - Validation oversight is required by CareerWise Recruitment for our Mid West based Biotech client. Please contact Diarmuid Buckley for full details. THE ROLE: * Reviews and performs final quality approval to Validation policies, plans, reports, protocols and deviations, ensuring that they are prepared and executed to the highest standards, complying with SOP and Regulatory requirements. * Scope includes but is not limited to: Equipment/Utility/Facility Qualification, Cleaning Validation & Steam Sterilisation Qualification, * Computer System Validation, Assay Validation and Process Validation. * Day to day management of the QA Validation Oversight team, planning and assigning responsibilities and tasks to Validations Specialists and. * Reviews validation protocol deviations, provides final quality approval and sign-off. * Provide leadership and tactical support for regulatory, partner and internal audits for the QA Validation organization. REQUIREMENTS: * Requires BS/BA in Engineering, Chemistry, or Life Sciences with a minimum of 9 years of experience, including at least 4 years in a validation and/or Quality Assurance organization. * Previous team/people management experience essential. * Understanding of Biopharmaceutical Drug Substance manufacturing process an advantage. Please call Diarmuid Buckley today for further information on 021- 4355432 or email: dbuckley@careerwise.ie. CareerWise Recruitment (In Search of Excellence. Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent. Please call Diarmuid Buckley today for further information on 021- 4355432 or email: dbuckley@careerwise.ie.

1186 days ago