Responsibilities

• Act as Quality Assurance approver for qualification/validation lifecycle documents.
• Serve as a quality assurance resource for assessing validation requirements, non-conformance, impact assessments, root cause analysis and implementation of CAPA found during CQV activities.
• Provide Quality Assurance Validation support for Steam In Place (SIP) of buffer and media preparation systems, upstream (bioreactors) and downstream equipment trains & Autoclave loads
• Provide Quality Assurance Validation support for the Cleaning Validation Program. Cleaning (CIP) cycles/ for buffer and media preparation systems, upstream (bioreactors) and downstream equipment trains, parts washers and supporting process equipment.
• 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 commissioning, qualification, and validation activities in a regulated environment.
• Technical knowledge of Cleaning validation/verification, quality systems and regulatory requirements.
• Experience in review and approval of Cleaning Validation studies.
• Experience in review of temperature mapping studies. Ex CTU’s, Autoclaves, SIP systems.
• Strong contemporary knowledge of relevant cGMPs, regulations and current industry trends.
• Experience with new product introductions and/or process qualification/technology transfer

To apply contact Martin Lynch on 087-344 3581.

Email CVs to mlynch@mile.ie