Cache of job #13970065

Job Title

QA Validation Manager (Cleaning & Sip)

Employer

Careerwise Recruitment

Location

Limerick

Description

QA VALIDATION MANAGER (CLEANING & SIP) required by CareerWise Recruitment for our multinational BioTech client in Limerick. The QA VALIDATION MANAGER (CLEANING & SIP) implements policies and procedures to validate/qualify equipment, systems, and processes in accordance with regulatory requirements and company manufacturing standards, and oversees a team of Validation Specialists. THE ROLE: * Manage, develop and build a team of subject matter experts in the areas of cleaning validation and SIP validation and continuing validation. * Day to day management of resources, planning and assigning work to Validations Specialists and/or contingent workers to meet goals and deadlines. * Ability to manage multiple and complex validation programs, provide status reports and coordinating with other departments or outside contractors/vendors to complete validation tasks. * Lead technical and quality investigations. * Collaborates with functional departments to resolve issues. * Manage a cross-functional projects with many stakeholders. * Reviews, edits and approves change controls, SOPs, reports and other documentation. * Review and/or approve master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria. * Reviews, edits and approves deviation notifications, deviation investigations, and corrective actions. * Trains/advises less experienced Specialists. * May present at both internal and external (regulatory) audits if required. * Stays current with industry trends, regulatory requirement updates, and communicating same to team. * Performs other duties assigned by Management. * Some travel may be required. REQUIRMENTS: * BS/BA in Engineering, Chemistry, or Life Sciences with 6 years of related experience within the field preferred; may substitute relevant experience for education. * Previous team/people management experience essential. * Previous cleaning validation and steam in place experience an advantage. * Understanding of Biopharmaceutical Drug Substance manufacturing process an advantage. Please call Conor Twomey today for further information on 021 4297422 or email: ctwomey@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. This job originally appeared on RecruitIreland.com.

Date Added

10 days ago

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