CQV Lead: Upstream / Downstream / Bioconjugation
CQV Lead: Upstream / Downstream / Bioconjugation
Jobdescription
For our client, an international company in Visp, we are looking for a CQV Lead.
The CQV Lead is primarily responsible for the preparation and the execution of the CQV activities relating to Upstream, Bioconjugation or Downstream Process Equipment. The target area will be assigned accordingly to the candidate's experience.
General Information:
Responsibilities:
Your Profile:
Nice to have:
For our client, an international company in Visp, we are looking for a CQV Lead.
The CQV Lead is primarily responsible for the preparation and the execution of the CQV activities relating to Upstream, Bioconjugation or Downstream Process Equipment. The target area will be assigned accordingly to the candidate's experience.
General Information:
- Start date: ASAP
- Contract duration: 1 year
- Workplace: Visp
- Workload: 100%
- Home office: not possible
Responsibilities:
- 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 / Downstream Buffer +
Filtration Systems / Bioconjugation Systems. - 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 / Downstream Buffer + Filtration Systems / Bioconjugation 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.
Your Profile:
- 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 / Downstream / Bioconjugation 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.
Nice to have:
- Fluent German
- Experience with COMOS/KNEAT platforms
- Biopharmaceutical knowledge
Luca Furler
Adresse
Randstad (Schweiz) AG
Über die Firma
