Qualification Engineer in Haarlem

3 weken geleden

Haarlem, Nederland Talentmark Voltijd
Join the Quality Analytical Laboratory in Haarlem as a Qualification Engineer Contribute to the validation and implementation of cutting-edge laboratory equipment while prioritizing projects and ensuring seamless execution. If you're a proactive team player with a background in chemistry or related fields, apply now
 

Company:
The headquarters is in Haarlem and hosts around 700 employees. The site is involved in the production, marketing, and sales of both generic and specialty pharmaceuticals, hospital products, and nutritional supplements.

Department Description:
The Quality Analytical Laboratory conducts all analytical testing to support the production of Cytotoxic and Inhalation drug products. We execute various analytical tests on APIs, excipients, packaging materials, and drug products for release and stability. Additionally, we handle the transfer, validation, and verification of analytical methods for testing new drug products. Our work involves a range of analytical techniques including GC, UPLC/HPLC, FT-IR, and UV-VIS.

Position Description:
  • Assess, qualify (including validation), and implement sophisticated high-end (computerized) laboratory equipment (e.g., GC, UPLC/HPLC, FT-IR, UV-VIS).
  • Prioritize projects and oversee project execution across multiple departments.
  • Ensure timely completion of all validation documentation, including coordination of contractor activities.
  • Present project status to stakeholders and senior management.
  • Develop training instructions, calibration, maintenance, operational procedures, equipment specification files, and reports (URS, Risk assessments, IQ/OQ/PQ).
 
Qualifications:
  • Minimum HBO in chemistry or related field.
  • Strong organizational skills.
  • Experience with scientific analytical approaches.
  • Proficiency in laboratory equipment calibration, qualification, and validation.
  • 4-5 years of experience in the Pharmaceutical industry or equivalent GMP environment, with at least 1 year focused on the validation of laboratory equipment.
  • Team player with excellent communication skills and a proactive approach.
  • Proficient in English document writing.

Duration:
One-year contract (With possibility for extension)

Offer:
Competitive market salary with attractive secondary benefits.

Hours:
Full-time (40 hours per week)

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