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Engineering & Technical

Scientific & Laboratory

Job Description

Excellent new opportunity for a Manager - QA Validation. This is a permanent opportunity with a top multinational in Limerick. This successful candidate will implement policies and procedures to validate/qualify equipment, systems, and processes in accordance with regulatory requirements and company manufacturing standards and oversee a team of Validation Specialists.

Role of this position

  • 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.
  • 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.
  • Some travel may be required from time to time.

JOB REQUIREMENTS

  • BS/BA in Engineering, Chemistry, or Life Sciences with 6+ years relevant experience within the Biopharma or Pharma industry; 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 Michelle Galvin today for further information on 091 373 938 or email: mgalvin@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.

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Engineering & Technical

Scientific & Laboratory

Cork Office

CareerWise Recruitment. EastGate Village, EastGate, Little Island, Cork.

Phone: +353 (0) 21 206 1900

Email: info@careerwise.ie