CSV Lead
- Netherlands, Eindohoven
- Contract
- Life Sciences
Do you want to be involved with exciting pharmaceutical projects?
When it comes to the development and production of veterinary vaccines, our pharmaceutical client has the largest centre in the industry worldwide and is a Centre of Excellence; employing more than 1000 people. They are looking to add to their team and require a CSV Lead.
Essential Duties and Responsibilities for this role include, but are not limited to, the following:
- Lead and manage the CSV team, ensuring timely completion of all deliverables.
- Develop all CSV master plans and documentation.
- Act as the lead engineer for review of PAS (existing and new), BMS, EMS, Data Historian (OSI Pi), and equipment PLC systems.
- Identify the full scope of computer system validation and qualification efforts (GMP and non-GMP).
- Create project-specific CSV plans for automation & IT systems, PAS, OSI-Pi, and standalone QC lab instruments.
- Support the automation group in field execution and final report writing.
- Lead and coordinate the APCC (Automation Project Change Control).
- Manage and control all automation lifecycle and testing documents.
- Generate all automation/CSV project templates.
- Support the Design Qualification effort with CSV and automation input.
- Attend risk assessment sessions (Complexity/Customisation, FMEA, PCL, CIL).
- Coordinate and manage all CSV vendors, from FAT/SAT/IOQ.
- Run and coordinate weekly CSV meetings, reporting to the CQV PM.
- Requires extensive experience implementing and managing CSV scope on large-scale projects.
- Proven experience delivering projects using a verification/leveraging approach to CSV.
- Experience working on complex projects within the biopharmaceutical industry.
#LI-DH1
I have always received a highly professional & personable service from the team at QCS Staffing. 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
We have worked together with QCS Staffing for seven years now and have always received a professional service. QCS Staffing'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 QCS Staffing'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
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Marcin
I manage this role.