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.
- 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 firstname.lastname@example.org
CareerWise Recruitment (In Search of Excellence)