Head of Cqv

Vor 3 Tagen

Bern, Schweiz Hobson Prior Vollzeit

Hobson Prior is working with a leading pharmaceutical organisation who are seeking a Head of CQV to join their team on a permanent basis and will have the ability to work remotely.

Please note that to be considered for this role you must have the right to work in this location.

**Key Responsibilities**:

- Perform work to meet budget requirements and quality standards. Provide consistent, complete, and timely feedback and reports to project managers or management of project status and issues. Develop project schedules, deliverable tracking reports, scope adjustment notices, etc.
- Support, train, and provide guidance to validation specialists/engineers in the delivery of C/Q/V services for assigned projects.
- Write and manage others in the preparation of C/Q/V documents following established standards and templates.
- Perform and manage others during field/site activities.
- Attend and witness FATs and SATs as a representative of IPS clients.
- Execution of commissioning forms and witnessing of vendor start-up and testing.
- Execution of C/Q/V protocols.
- Walkdown and verification of system drawings.
- Perform and manage staff in compiling data packages and prepare reports for completed C/Q/V activities including ETOPs, protocol data packages, etc.
- Assist in deviation investigation and resolution of problems and issues encountered during field execution activities.
- Coordinate with the Project Delivery department or CM for start-up and vendor testing. Witness and troubleshoot as required.
- Audit project deliverables to assure compliance with established standards. Review work of assigned project team.
- Assist in proposal development including scope definition, attend bid meetings, development of hours and cost budgets, proposal presentations, etc.
- Act as an IPS representative for developing new opportunities and continue to support repeat business.
- Primary responsibilities include C/Q/V of equipment and systems, including CSV and automation, supporting pharmaceutical, biotech, and medical device industries.
- Must be self-sufficient and effectively work with limited to no supervision.
- Read, understand and utilise the IPS Best Practices and SOPs for delivery of compliance services.
- Other duties as assigned.

**Requirements**:

- Degree educated in Engineering or Natural Sciences discipline, preferably in Biology, Microbiology or Biotechnology
- 10+ years of industry experience in Pharmaceutical, Biotech, Medical Device Design, Commissioning or Validation.
- Possess a minimum of 5 years of developing and leading either in direct or in project lead capacity teams of qualification and validation experts.
- Experience in writing and execution of PFC, FC, IQ, OQ, and PQ forms and protocols for GMP Utilities, Equipment, Systems, and Software.
- General exposure and experience in a GMP/Validation discipline with a knowledge and understanding of pharmaceutical Design/Build/Commission/Validate processes and how they relate to regulatory requirements and cGMP regulations within the EU and US FDA.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

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