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Engineering & Technical

Job Description

A Sr QA Validation Specialist is required by CareerWise Recruitment for our Limerick based client. Validate/qualify equipment, systems, and processes in accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and procedures.

Role of this position

  • Responsible for all aspects of the Cleaning Validation programs onsite for a large-scale Biopharmaceutical Drug Substance production facility.
  • Analyses the results of testing and determines the acceptability of results against pre-determined criteria.
  • Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.
  • Reviews, edits and approves deviation notifications, deviation investigations, and corrective actions.
  • Reviews, edits and approves change controls, SOPs, reports and other documentation.
  • Generates, executes and/or reviews master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria.

JOB REQUIREMENTS

  • BS/BA in Engineering, Chemistry, or Life Sciences.
  • 5+ years of related experience within the field of Cleaning Validation in Biopharmaceutical, Aseptic Fill/Finish or API manufacturing.
  • Basic knowledge of regulatory compliance inclusive of cGMP, FDA regulations, familiarity with ICH guidelines and EU regulations.

Please call Lisa Casserly today for further information on 091-339136 or email: lcasserly@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

Cork Office

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

Phone: +353 (0) 21 206 1900

Email: info@careerwise.ie