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Engineering & Technical

Job Description

A Quality Auditor is required by CareerWise Recruitment to work with a Dublin based Biotechnology Company on an initial 11 month contract.

Role of this position

  • The Quality Auditor conducts routine audits of data, information, procedures, equipment and systems (including computer systems), and/or facilities to ensure the compliance with SOP's and GMP's and worldwide regulations.
  • Review and approve production and analytical documentation accompanying the release of API, Safety Assessment or clinical supply lots (bulk and packaged) to ensure conformance to appropriate regulatory requirements.
  • In addition, the Auditor communicates and resolves audit comments with client areas.
  • Under supervision, or as part of a team, perform audits or inspections of assigned areas or systems to assess compliance with regulatory and Company standards.
  • Issue reports summarizing deficiencies and work with areas to execute remedial action.

JOB REQUIREMENTS

  • Bachelor's degree (or higher) in Engineering, Chemistry, Biology, or relevant discipline,
  • The successful candidate will also ideally have a proven track record in delivering excellence.
  • This role requires a minimum of 5 years' experience in, Quality Assurance, Technical Operations or Engineering within the Biopharma / Pharmaceutical industry.
  • Experience working in regulated environment with exposure in the Regulations & guidance's - GMP, CGMP, GAMP, 21 CFR Part 11
  • Experience in batch record review and review of batch related documentation.

Please call Laura Callinan today for further information on 091 - 339 136 or email lcallinan@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