quality assurance senior associate in Solothurn area

Margaret Chat-Jasiolek, Geneva Professionals Health Care & Life Sciences
job type
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job details

solothurn area
Life Sciences
job type
reference number
margaret chat-jasiolek, geneva professionals health care & life sciences
058 201 54 40
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job description

Quality Assurance Senior Associate

This position requires experience in commissioning/qualification activities in the GMP environment of Life Sciences / Pharma / Biotech Upstream/Downstream or Fill Finish manufacturing facilities. The candidate should have good experience of all project phases, including design, construction, C&Q and operational readiness. During the period of establishing the new manufacturing site the position holder will be part of the facility program and coordinate as well as oversee commissioning and qualification activities as QA representative in the program matrix structure. In the operational phase of the plant the position holder is part of the Qualification / Validation team overseeing the yearly requalification activities and is responsible to represent QA in project based qualification activities.


Main Responsibilities and Accountabilities:


Is responsible as QA representative to oversee and reviewing FAT and SAT activities/reports/protocols.

The position holder ensures that the Quality by Design (QbD) principles are integrated into elements leading to qualification activities. The responsibilities includes QA-review/approval/establishing.

A collaborative working approach between all stakeholders ensures that qualification activities are planned and delivered in an efficient timeframe.

QA representatives are involved in the preparation and attendance to health authority inspections within their area of responsibilities.


Qualifications & Experience:

  • Degree (Bachelor or Masters) in Engineering or Life Sciences (Biology, Chemistry, etc.), Dipl. Ing. or M.Sc. or B.Sc. or equivalent
  • Qualification experience preferably gained on a Life Sciences / Pharma / Biotech Upstream/Downstream/Fill Finish manufacturing facility
  • Several years of successful commissioning and/or qualification experience on mid-sized and major projects with high complexity in the chemical, biotech-or pharmaceutical industry
  • Proven experience and knowledge in chemical, biotech or pharmaceutical process, automation and engineering
  • Proven experience in cGxP and qualification/ validation
  • Language: Fluent German required, with some proficiency in English beneficial (written and spoken)
  • Able to work well both independently and in a team environment to ensure successful outcomes.
  • Excellent time management skills, with the flexibility to manage changing priorities and multiple tasks.