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16007en
- Contract
- English, French
- Entry level
- Engineering & Technical Services
- Neuchâtel
- Healthcare & Life Sciences
On behalf of our client, a leading global pharmaceutical company, we are looking for a QA engineering/Validation Expert to join the Quality engineering department.
Start Date: As soon as possible
Location: Neuchatel
Work type: Minimum 4 days on site per week.
Workload: 100%
Duration: 8 months
Extension: Possible
Your mission:
- Review deviations in the framework of engineering events within quality systems (i.e. Trackwise) to verify acceptability and adherence to standard procedures and regulatory
requirements. This includes conducting or approving the relevant investigations, impact assessments (related to impact on concerned equipment/product/material) and definition of
relevant CAPA.
- Review and approve Engineering controlled documentation being revised
- Review and approve requalification of Cleaning in place /sterilization in place/ Temperature control unit and review/approve protocol deviations related to.
- Perform the assessment of change control from a Quality Engineering standpoint
- Attend all meetings relevant to perform the above-mentioned tasks
- Respect the escalation process
- Ensure completion of relevant training and software access management according to the company’s policies
Your background:
- Technical or scientific academic background
- Languages: Fluency in French and English min level B2
- 2-3 years' operational cGMP experience in a Quality Ops or Engineering department at a Manufacturing site in the Pharmaceuticals, Biotech and/or Sterile Injectables industries
- Knowledge of Quality standards (cGMP) and Quality Systems (Deviations, CAPA, Change Control, Training, Documentation, etc.)
- Technical knowledge of maintenance, facilities/utilities, HVAC, calibration would be a plus.
- Ability to write documents in French and/or English, and to read documents in French and English.
If this sounds like you, don’t hesitate to apply here or reach out directly to Veronika von Mentzer, Recruiter: veronika.nakev@swisslinx.com
Start Date: As soon as possible
Location: Neuchatel
Work type: Minimum 4 days on site per week.
Workload: 100%
Duration: 8 months
Extension: Possible
Your mission:
- Review deviations in the framework of engineering events within quality systems (i.e. Trackwise) to verify acceptability and adherence to standard procedures and regulatory
requirements. This includes conducting or approving the relevant investigations, impact assessments (related to impact on concerned equipment/product/material) and definition of
relevant CAPA.
- Review and approve Engineering controlled documentation being revised
- Review and approve requalification of Cleaning in place /sterilization in place/ Temperature control unit and review/approve protocol deviations related to.
- Perform the assessment of change control from a Quality Engineering standpoint
- Attend all meetings relevant to perform the above-mentioned tasks
- Respect the escalation process
- Ensure completion of relevant training and software access management according to the company’s policies
Your background:
- Technical or scientific academic background
- Languages: Fluency in French and English min level B2
- 2-3 years' operational cGMP experience in a Quality Ops or Engineering department at a Manufacturing site in the Pharmaceuticals, Biotech and/or Sterile Injectables industries
- Knowledge of Quality standards (cGMP) and Quality Systems (Deviations, CAPA, Change Control, Training, Documentation, etc.)
- Technical knowledge of maintenance, facilities/utilities, HVAC, calibration would be a plus.
- Ability to write documents in French and/or English, and to read documents in French and English.
If this sounds like you, don’t hesitate to apply here or reach out directly to Veronika von Mentzer, Recruiter: veronika.nakev@swisslinx.com
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