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Validation Engineer

Validation Engineer

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Validation Engineer

  • Location:

    Switzerland

  • Sector:

    Quality Assurance & Validation

  • Contact:

    Phil Turner

  • Salary:

    Negotiable

  • Job type:

    Interim/Contract

  • Contact email:

    pharmajobs@msigroupltd.com

  • Job ref:

    VR/03755_1622640426

  • Published:

    12 days ago

  • Duration:

    6 months

  • Startdate:

    ASAP

MSI Pharma are currently looking for a Commissioning and Quality Engineer based in Switzerland.

In charge of commissioning and qualification (C&Q) activities for Technical Services department in order to ensure that:
- Qualification/Validation phases are performed according to global and local company policies and procedures as well as legal requirements and requirements set by regulatory authorities
- Qualification/Validation Master plans are up to date and established for all ongoing projects in QC
Plan, coordinate and execute all phases for qualification of GMP manufacturing systems including but not limited to, Qualification/Validation plans, FMEA, DQ, IQ, OQ, PQ.
Prepare, review and approve technical and GMP related documentation (URS, impact/risk assessment, Master plans, qualification/validation documentation)
Coordinate and execute FAT/SAT, commissioning activities for new manufacturing systems in collaboration with internal and external partners
Coordination and oversight of external suppliers
Operational handling of Change Controls, CAPAs and Non-Conformances related to qualification topics

Qualifications:
Bachelor/Master Degree in technical or natural sciences
A minimum of 3 years of working experience within pharma company in C&Q equivalent position
Know-how of Commissioning and Qualification requirements according to cGMP regulations and international guidelines
Business fluency in English
German language is a plus