DSP / USP Manufacturing Consultant

DSP / USP Manufacturing Consultant

Location: Vevey, Switzerland

Duration: 4 months initial

Workload: 100% fulltime

Tasks:

• Perform Electronical Batch Review (EBR) in MES
• Lead and close as per plan deviations, investigations, CCP actions and CAPAs
• Accountable for the respect of quality standards, GXP rules and ensure safety in the areas under its responsibility
• Maintain his/her training plan up-to-date
• Speak up as soon as an unexpected event appears
• Be compliant in his/her scope of activities by ensuring full traceability of his/her activities. Know and follow EHS rules applicable to workplace activities.
• Identify and report immediately situations that are hazardous to self, co-workers or the environment (pollution hazard).
• Stop all activities if EHS risks are not controlled.
• Wear personal protective equipment, use safety devices correctly and refrain from removing or modifying them without management authorization.
• Suggest improvements and take associated actions to avoid exposing oneself or others to danger.
• Provide feedback when risky behavior is observed.

Requirements:

• At least 3 years‘ experience in Chemistry, Biology or Biotechnology (or equivalent)
• Bachelor or Master Degree in Engineering or Technical degree with several relevant industry experience
• Fluent in English, French is a plus
• Deep knowledge of Upstream and Downstream Process (fed-batch and perfusion)
• Deep knowledge of MES. Able to perform EBR review
• Knowledge of BPF and GMP
• Knowledge of IT tools (Pack Office, Trackwise/ SAP, MES, LIMS) is a plus
• Able to work as part of a team and have good communication skills with all stakeholders (Managers, Unit managers, scientists and technicians) and stakeholders from other departments (Production, QC, QA…)
• Ideally experience in the field of pharmaceutical production (USP, DSP clinical and/or commercial)
• Valid Swiss Work Permit or EU-Citizenship

Sthree Switzerland is acting as an Employment Business in relation to this vacancy.

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