CSV Lead
- Germany, Frankfurt
- Contract
- Life Sciences
We are recruiting on behalf of a leading global pharmaceutical client based in Frankfurt, Germany. Due to a large capital investment and multiple projects on site, the client is looking for a CSV Lead to join their team.
Responsibilities include:
- 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 life-cycle 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.
- 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.
If you are local to Frankfurt ,Germany and interested in discussing this position, please submit your profile and we will be in contact at our earliest convenience.
#LI-AB3
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
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
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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