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Validation Specialist (C&Q/CQV Engineering)

Experis AG

Posted on Oct 14, 2021 by Experis AG

Bern, Switzerland
Research
Immediate Start
Annual Salary
Contract/Project

Validation Specialist (C&Q/CQV Engineering)

Our Pharmaceutical client in Bern (Switzerland), is looking for a motivated team member.

Tasks & Responsibilities:

The position will report to the C&Q Manager and oversees Commissioning & Qualification (C&Q) activities for Technical Services department 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
  • Write/review Qualification/Validation plans, including but not limited to DQ, IQ, OQ, PQ plans/protocols and final reports for new or modified GMP utilities, facilities, and process equipment
  • Execution of DQ, IQ, OQ, PQ, including protocol deviations, investigation, and corrective action activities for new or modified GMP utilities, facilities, and process equipment
  • Plan and track execution of Commissioning & Qualification activities/documentation versus project(s) timeline
  • Prepare, review and approve technical and GMP related documentation (URS, FMEA, impact/risk assessment, Master plans, qualification/validation documentation)
  • Coordinate and execute FAT/SAT, commissioning activities for new GMP systems in collaboration with internal and external partners
  • Coordination and oversight of external suppliers

Must have:

  • Bachelor/Master's degree in technical or natural sciences
  • 5 years working experience in a Pharma/Medical Devices company in C&Q/CQV equivalent position
  • Know-how of Qualification requirements according to cGMP regulations
  • Experience working with cross-department stakeholders
  • Know-how of quality assurance principles

Nice to have:

  • Experience working in project teams and multiple projects in parallel
  • Experience working with ISPE baseline guide vol 3, vol 4 and vol 5
  • Know-how of thermomapping studies

Language skills:

  • Business fluency in English
  • German language is a plus

General Information:

  • Start date: ASAP
  • End date: 6 months
  • Workload: 100%
  • Work Location: Bern

For further information, please contact your Experis Recruiter, Elaine Kanwar or email your CV or apply directly online.

Reference: 1360604951

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