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QA Validation Specialist / Engineer

Engineering
Dublin
Temporary
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Job Reference: JO-2004-65163_1588232503

Summary:

Summary:


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.



Responsibilities:


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.



Requirements:



  • 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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