Qualification Engineer

☞ Manpower

Aussicht: 172

Update Tag: 10-04-2024

Ort: Saint-Prex Vaud VD

Kategorie: Pharma / Chemie / Biotechnologie

Industrie:

Jobtyp: 100%

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Jobinhalt

For our client, an international biopharmaceutical company, active in the fields of reproductive health, urology, gastroenterology, endocrinology and orthopaedics, we are looking for a :
Your mission
Within the Plant Performance & Process Excellence team, the qualification engineer will ensure the activities of qualification for manufacturing and packaging equipment, in due time and in line with defined quality standards, in collaboration with Production, supply chain, engineering, maintenance / automation and QA department. Your profile
  • Manage assigned tasks, according to the defined deadlines and priorities
  • Write Qualification protocols and finalize documentation associated to reports (commissioning, IQ, OQ, PQ),
  • Write and follow the deviations linked to qualification, in collaboration with subject matter experts
  • Assess the progress of planned phases
  • Coordinate internal staff for qualification activities (maintenance technician, operator)
  • Manage the execution phase until the successful release with an end to end vision
  • Lead risk analysis in collaboration with subject matter experts,
  • Ensure the execution of the qualification tests on production equipment (manufacturing and packaging)
  • Propose continuous improvement and LEAN: propose solutions and participate for implementation

  • Master degree in Pharmacy, Chemistry, Engineering or alternative technical/science university degree
  • Minimum of 3 years’ experience in qualification activities in pharmaceuticals industry
  • Excellent knowledge of relevant GMP and international quality regulations
  • Knowledge in manufacturing environment
  • Sound knowledge of written and spoken French and English is required
  • Strong and effective verbal and written communication skills
  • High level of autonomy and energy
Interested?
Temporary contract
Star date : ASAP
Duration : 7/8 mois
Based in St Prex (Vaud) – 100%
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Frist: 25-05-2024

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