CQV Lead: Upstream

Vor 5 Tagen

Visp, Schweiz Randstad Vollzeit
Jobdescription
For ourclient, an international company in Visp, we are looking fora CQV Lead.

The CQV Lead is primarilyresponsible for the preparation and the execution of the CQVactivities relating to Upstream, Bioconjugation or DownstreamProcess Equipment. The target area will be assigned accordingly tothe candidate's experience.

General Information: 
  • Start date:ASAP
  • Contract duration: 1year
  • Workplace:Visp
  • Workload: 100%
  • Homeoffice: not possible


Responsibilities:
 
  • Self-manage CQ development andexecution activities with respect to the relevantsystems.
  • Function as a key member of the CQTeam, and provide guidance regarding Upstream Process Equipment/  Downstream Buffer +
    Filtration Systems/ Bioconjugation Systems.
  • Maintain controlover the activities and schedule with respect to the relevantsystems.
  • Participate in sessions todefine/agree work breakdown structure with respect to the relevantsystems
  • Assist in assessing project risk andevaluating the effectiveness of mitigation strategiesapplied.
  • Coordination and communication withother resources for Upstream Systems / Downstream Buffer +Filtration Systems / Bioconjugation Systems -relatedmatters.
  • Adherence to projectprocedures/requirements with respect toHealth/Safety/Environmental, Quality (including GDP/GMP), CQ(including MCP, MQP, DQ, IQ, OQ,Commissioning).
  • Liaise closely with therelevant vendors/providers/contractors, project Automationrepresentatives and Construction-phase representatives to ensureintegration of activities and schedules with respect to therelevant systems.
  • Actively participate in thedevelopment and delivery of deliverables with respect to therelevant systems.
  • Report on key deliverable anddates and align with key milestones within the project’s criticalpath.
  • Report and aid in the resolution ofproject issues, including maintaining the non-conformancerecords.
  • Assist in assessing project risk andevaluating the effectiveness of mitigation strategiesapplied.
  • Prioritize and execute tasks in afast-paced environment.


Your Profile:
 
  • MinimumBachelor’s degree in Life Sciences orEngineering
  • Minimum of 6+ years of experiencein commissioning / qualification / validation (DQ, IQ, OQ,Commissioning) activities in the pharmaceutical/biotechindustry.
  • Proven Upstream / Downstream /Bioconjugation system and CIP / SIPknowledge.
  • Minimum 6+ years of experience incommissioning / qualification / validation of Downstreamsystems.
  • Experience with DeltaV(Emerson).
  • Fluent English language written andverbal communication skills.
  • cGMP knowledge andknowledge of regulatory requirements.
  • Able towork with minimum oversight fulfilling deliverables within targetdates.


Nice tohave:
  • FluentGerman
  • Experience with COMOS/KNEATplatforms
  • Biopharmaceuticalknowledge

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