Scientific Product Specialist

1 maand geleden


Amsterdam, Noord-Holland, Nederland Santen Voltijd
Job Description

Santen is seeking a highly skilled Scientific Product Specialist to join our team. As a key member of our analytical sciences team, you will be responsible for providing expert support for all analytical test methods specific to our products. Your primary focus will be on ensuring the execution of on-time product release, continuously improving product quality and analytical procedures, and ensuring compliance to cGxP, SOPs, and international guidelines and regulations.

Responsibilities:

  • Provide front-line support to the product manufacturing process, analytics, release testing, and QC teams.
  • Support the execution of analytical methods qualifications and validations, re-validations, and annual monitoring batch (AMB) projects.
  • Drive the qualification and/or validation of primary packaging materials testing methods, including container suitability studies.
  • Ensure consistency of analytical testing procedures and derive control limits for each product analytical method.
  • Lead and/or support the investigation and resolution of product and process-related analytical deviations, complaints, and out-of-specification events.

Requirements:

  • BSc. or MSc. in Pharmacy, Pharmaceutical Technology, Chemistry, Engineering, or other scientific degree.
  • Fluent English language skills.
  • Minimum 5 years' experience in a QC/IPC laboratory scientist role in a pharmaceutical or chemical GMP environment.
  • Basic knowledge of current CPV/OPV product and process data analysis and monitoring tools.

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