Validation Engineer

Vertragsart:
Vor Ort
Start:
ASAP
Dauer:
6 months
Von:
Quanta Consultancy Services
Ort:
CH
Eingestellt:
19.08.2017
Land:
flag_no Schweiz
Projekt-ID:
1401527

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Our Pharmaceutical client based in Switzerland requires a Validation Engineer to join them on an initial 6 month contract.
Duties:
  • Write and execute qualification protocols; IQ, OQ, PQ.
  • Write equipment risk assessments (critical component assessments), Validation Plans, Requirement Tractability Matrix and qualification reports.
  • Co-ordinate qualification execution activities, including external vendors, internal departments, organising materials, etc.
  • Manage associated qualification deviations & CAPAs, including opening, resolution (with suppliers) and closure.
  • Participate in the creation and review of process Risk Assessments.
Requirements:
  • Fluent French speaker.
  • Excellent English literacy.
  • Knowledge of Pharmaceutical (solid dosage) facilities would be advantageous.
  • Experience with equipment qualification including IQ, OQ and PQ.
  • Competent with current FDA and EU regulatory regulations and best practices, including GAMP.
  • Committed team player.
  • Excellent interpersonal skills.
  • Flexible, keen to learn, adapt and integrate.