CQV Lead – HVAC & Clean room
- Dublin
- Contract
- Commissioning, Qualification and Validation
This vacancy has now expired
Would you like to grow your career, whilst contributing to scientific innovations that are transforming patients’ lives? Our client, a globally renowned biotechnology organisation, and voted one of the top 10 best companies to work for in Ireland, is looking to recruit a CQV Lead to join their team.
Responsibilities:
- Act as CQV subject matter expert for HVAC & Clean rooms.
- Review and approve vendor documentation.
- Witness vendor qualification activities (FAT, SAT and IOQ).
- Define DQ,IQ,OQ, PQ, PPQ qualification strategy.
- Document and supervise qualification activities.
- Define and compile defects libraries for qualification.
- Oversee and coordinate the generation of bridging data.
- Liaise with CQV PM and Lead Scheduler in relation to schedule creation and management for all Systems, ensuring all correct predecessors and successors are in place.
- Ensure Commissioning readiness of all Systems to support Equipment Start-up and IOQ Testing.
- Design/CM/CQV/Automation/Process/SMEs/Ops/Maintenance/PMs) to ensure all Systems are managed appropriately for the Project Lifecycle.
- Liaise with CQV Document Generation Lead in relation to generation and approval of; DQ/Design Reviews/SLIA/Test Matrices/Risk Assessments/QA Ven. or Assessments/FAT/SAT/CTP/IOQ Protocols
- Lead execution of all CQV deliverables; IOQ, field execution
- Generate and ensure timely approval of all Commissioning and IOQ Final Reports.
Requirements:
- Experience with CQV of HVAC & Clean rooms
- Leading CQV Teams on start up projects.
- Familiar with and regulatory requirements (minimum US and EMA).
- Minimum of 8-year experience in the pharmaceutical industry, preferably in sterile labs, QC and/or Production.
- Team player with strong communication skills
- Experience in coordinating diverse teams within a matrix environment.
- Good technical writing skills
- Reliable execution
If this role is of interest to you, please apply now!
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta part of QCS Staffing does not sponsor Visa applications.
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We have worked together with Quanta for seven years now and have always received a professional service. Quanta’s speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of Quanta’s people and their ability to deliver.
Global Pharmaceutical firm
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
I have always received a highly professional & personable service from the team at Quanta. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
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