Job Reference: JO-2004-65163_1588232503
The role is a traditional Quality Assurance Validation Specialist position which will act as point of contact for the Performance Qualification manufacturing systems in Dublin. The candidate will be responsible for the co-ordination, review and approval of all life-cycle documentation associated with the SIP strategy.
The Quality Engineer is responsible for classification of laboratory systems, whether computerized; Reviewing and writing qualification documents (URS, protocols / reports, etc.); Close contact with the internal customers; Verification of qualification documents produced by outside companies. Minimal work direction needed, highly skilled and knowledgeable to the position. The successful candidate would also need to:
- Act as Quality Assurance approver for qualification/validation life-cycle 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.
- Will serve as the Quality SME for all validation activities across the site including but not limited to Steam in Place(SIP), Cleaning Validation & CTU (Controlled temperature Unit) Performance qualification.
- 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.
The Quality Assurance Validation Specialist will report to the CQV Quality Lead.
- Bachelor's degree (or higher) in Engineering, Chemistry, Biology, or relevant discipline,
- This role requires a minimum of 3 years experience in, Quality Assurance,Technical Operations or Engineering within the Bio-pharma / Pharmaceutical industry.
- A self-starter and results-focused, the successful candidate will have strong contemporary knowledge of relevant cGMPs, regulations and current industry trends.
- Experience working in 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 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.
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