Role: The CQV Site Manager reports to the Site Project Manager and CQV Department Manager and is accountable to coordinate CQV resources, deliverables and activities from the validation approach definition, design review, turn-over systems definition all C&Q activities on site.
Suitable applicants must have must have the following Qualifications Key Competencies:
- Degree or equivalent in an engineering related discipline plus 10+ years of experience in commissioning and qualification activities on Pharmaceutical and or Biopharmaceutical Projects.
- Strong leadership skills and be a team player ability with proven ability in liaising directly with client and other project key functions.
- Previous experience as manager/leader of C&Q team.
- Strong knowledge of ISPE and ASTM E2500
- Adherence to CQ plans for labs and process equipment scope and input to scheduling activities.
- Oversight and implementation of the client CQ Program, ensuring a quality delivery.
- Training of team members in delivery approach including KNEAT.
- Planning, scheduling, and management of FAT attendance.
- Overview of protocol development and execution activities for the Design review, Installation Verification and Operational Verification aspects.
- Technical oversight and guidance to the CQ team.
- Safety oversight of the CQ team, in collaboration with the project safety team.
- Oversight of Change Management activities during project lifecycle.
- Summary Report writing/ metrics / schedule reviews.
- Provide leadership to the C&Q teams on site.
- Forecast needs from various stakeholders and ensure timely intervention to meet schedule.
- Drive the project on schedule.
- Interfacing with Client representatives on project team, Engineering Team, Quality team and End Users during the different project phases.
For further information or to apply please contact: Tom Doyle at kppm. P: 086 8205038. E: email@example.com
or email firstname.lastname@example.org
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