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Stability Control Specialist

Viatris · Greater Istanbul

Junior 🇬🇧 English
LIMS stability testing cGMP GLP data integrity laboratory instruments

Job description

About the role

Viatris is seeking a Stability Control Specialist to ensure the integrity and compliance of stability testing for pharmaceutical products. You will work within the Quality Control laboratory, applying cGMP, GLP and data‑integrity standards to support product release and regulatory submissions.

Key responsibilities

  • Perform technical control of stability testing and authorize results in the LIMS system according to specifications, cGLP, cGMP and EHS rules.
  • Participate in stability and finished‑product testing as required.
  • Assist with scheduling sample pulls, testing timelines and reporting deadlines for the Site Stability Program.
  • Label stability samples, verify correct placement in chambers and ensure accurate sample quantities.
  • Write laboratory investigations, deviations and determine corrective and preventive actions (CAPAs).
  • Prepare stability protocols, trend reports, annual and monthly plans.
  • Draft and update SOPs, product specifications and test methods, providing related training.
  • Support LIMS administrative activities to prevent delays in manufacturing or analysis approvals.

Required profile

  • Bachelor’s degree in Chemical Engineering, Chemistry, Pharmacy or a related discipline.
  • Minimum 2 years of experience in a pharmaceutical Quality Control laboratory.
  • Strong knowledge of cGMP, GLP and data‑integrity requirements.
  • Excellent verbal and written communication in Turkish and English.
  • Ability to work effectively in a matrix environment.

Required skills

  • LIMS operation and administration
  • Stability testing procedures
  • cGMP and GLP compliance
  • Data‑integrity practices
  • Laboratory instrument handling
  • SOP development and maintenance
  • Protocol and report preparation
  • Sample labeling and tracking
  • Product specification writing

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Published 1 ay önce

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Viatris

Greater Istanbul