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Engineering & Technical

Job Description

A Senior QA Validation Manager is required by Careerwise Recruitment to work for our Limerick based client.

Role of this position

  • Developing validation approaches with CMC teams such that external validation efforts align with commercial expectations and are timely with regards to planned regulatory filing dates.
  • Reviews and approves validation documentation associated with filling, visual inspection, labelling, assembly, product sterilization, packaging and technology transfer. Documentation may include Validation plans, development reports, process control strategies, protocols, reports and risk assessments.
  • Reviews Regulatory filing sections related to completed external validation activities.
  • Interfaces routinely with internal teams including CMC, Drug Product, External Manufacturing, QC, QA and Regulatory.

JOB REQUIREMENTS

  • BS/BA in Engineering, Chemistry, or Life Sciences with 8+ years of related experience within the field of Biotech Process sciences, Validation, Manufacturing or related field.
  • Experience in cGMP operations and managing of personnel is required.
  • Travel estimated at 30-50%.

Please call Michael O'Connor today for further information on 091-452410 or email moconnor@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