CQV Lead

vor 1 Monat

Visp, Schweiz Randstad Vollzeit

For Lonza SGIE AG in Visp we are looking für a CQV Lead 100% (f/m/d).

The CQV Lead Upstream is primarily responsible for the preparation and the execution of the CQV activities relating to Upstream Process Equipment.

Accountabilities

  • Self-manage CQ development and execution activities with respect to the relevant systems.

  • Function as a key member of the CQ Team, and provide guidance regarding Upstream Process Equipment

  • Maintain control over the activities and schedule with respect to the relevant systems.

  • Participate in sessions to define/agree work breakdown structure with respect to the relevant systems

  • Assist in assessing project risk and evaluating the effectiveness of mitigation strategies applied.

  • Coordination and communication with other resources for Upstream Systems-related matters.

  • Adherence to project procedures/requirements with respect to Health/Safety/Environmental, Quality (including GDP/GMP), CQ (including MCP, MQP, DQ, IQ, OQ, Commissioning).

  • Liaise closely with the relevant vendors/providers/contractors, project Automation representatives and Construction-phase representatives to ensure integration of activities and schedules with respect to the relevant systems.

  • Actively participate in the development and delivery of deliverables with respect to the relevant systems.

  • Report on key deliverable and dates and align with key milestones within the project's critical path.

  • Report and aid in the resolution of project issues, including maintaining the non-conformance records.

  • Assist in assessing project risk and evaluating the effectiveness of mitigation strategies applied.

  • Prioritize and execute tasks in a fast-paced environment.

    Qualifikationen

    • Minimum Bachelor's degree in Life Sciences or Engineering

    • Minimum of 6+ years of experience in commissioning / qualification / validation (DQ, IQ, OQ, Commissioning) activities in the pharmaceutical/biotech industry.

    • Proven Upstream system and CIP / SIP knowledge.

    • Minimum 6+ years of experience in commissioning / qualification / validation of Downstream systems.

    • Experience with DeltaV (Emerson).

    • Fluent English language written and verbal communication skills.

    • cGMP knowledge and knowledge of regulatory requirements.

    • Able to work with minimum oversight fulfilling deliverables within target dates.

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