15720 – QA Validation Specialist – Dublin Contractor

This is a 12- month contract with our pharma client in Dublin.

Purpose:

This role requires a minimum of 3 years of experience in, Quality Assurance, Technical Operations, or Engineering within the Biopharma / Pharmaceutical industry. A self-starter and results-focussed, the successful candidate will have strong contemporary knowledge of relevant cGMPs, regulations, and current industry trends. The Quality Assurance Validation Specialist will report to the CQV Quality Lead.

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.

Minimum Qualifications & 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. The candidate will also show ambition and drive to develop and advance their career.
• Experience working in a regulated environment with exposure in the Regulations & guidance’s – GMP, CGMP, GAMP, 21 CFR Part 11
• Must have at least 3 years of 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 , Autoclaves, SIP systems