A CQV Lead is required for a leading Biopharmaceutical multi-national client in the Dublin area for a 12 month contract. The Compliance Lead will review Verification documentation generated and executed using the Risk Based Verification (RBV) approach in our client’s cGMP Bulk Drug Substance (BDS) manufacturing plant The Compliance Lead will assure cGMP compliance before, during and after verification/qualification activities.
– Responsibility for maintenance of CQV Procedures throughout the project
– Ensuring adherence to CQV procedures during the CQV execution phase
– Execute training, as appropriate, on relevant CQV Procedures when revised
– Pre-Approval and Post-execution coordination of Verification Documentation with CQV, QA, Documentation Control.
– Support CQV leads with matters relating to Commissioning Engineering Change Control.
– Liaise with CQV area leads, Quality and Design SMEs on preparation and execution of significant deviations.
– Carry out regular Audits on all matters relating to CQV Verification documentation execution.
– Execute technical and GDP review on executed Commissioning Verification documentation.
– Coordination of OPs technician ‘second-pair-of-eyes’ review of CQV documentation.
– Driving RFT improvement strategies, communicating metrics and providing coaching to CQV team.
– Management of CQV executed VTSs lessons learnt, and CQV team communication.
– Maintaining CQV team ‘gold standard’ executed documents examples.
– Creation & agreement of dry-run examples of executed CQV VTSs.
– Creation of FV & PQ gating Go/No Go pre-requisites, and managing gate achievement on per-system basis.
– Periodic review of procedures effectiveness – ECM/ACP etc.
– Understanding and applying industry specific compliance standards/regulations to all CQV activities.
– Leading Risk assessments, root cause analysis and investigations.
– Review of protocols, reports, project change controls and deviations.
– Proactively highlighting any issues around compliance.
– Participates in internal and external audits and inspections where required.
– Commissioning, qualification and validation experience and / or Quality Assurance experience in a Bulk Drug Substance Manufacturing Facility (min 2 – 5 years).
– Experience in bioprocess manufacturing experience in an established biotech production operation.
– Experience in using DeltaV automation platform and review/approval of associated documentation preferred.
– Experience in issue description, root cause identification, technical/quality impact assessment & corrective action justification.
– Experience in quality assurance environments, quality management systems and GMP change management processes and impact assessments would be an advantage..
– Good general knowledge on Quality, cGMPs, ICH and ISO & strong technical writing and communication skills.
Technical diploma or Degree in Engineering/Life Sciences or greater preferred.
Call Kieran today for further discussiion on 021 4777329 or apply direct to this vacancy via this advert with an up to date CV in Word format.