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Analista de Desarrollo y Validación de Métodos

PiSA Farmacéutica · Kumarsain

🇪🇸 Español

Job description

About the role

The position is responsible for developing, validating, and transferring analytical methods in compliance with regulatory requirements to ensure the quality of new products, reformulations, and related inputs.

Key responsibilities

  • Perform activities aligned with the Quality System and Good Manufacturing Practices (GMP).
  • Develop and validate analytical methods for active ingredients, excipients, new products, and reformulations.
  • Transfer validated or verified methods to production, ensuring regulatory compliance.
  • Document results accurately to meet business unit objectives.
  • Apply statistical analysis to support process control and improvement.

Required profile

  • Bachelor’s degree in Chemical‑Pharmaceutical, Chemical‑Biological, or related fields.
  • Experience in the pharmaceutical industry handling laboratory equipment.
  • Availability to work rotating shifts.
  • Commitment to a safe, inclusive, and non‑discriminatory workplace.

Required skills

  • Operation of laboratory instruments (dissolvers, analytical balances, potentiometer).
  • Analytical method validation and transfer.
  • Gas chromatography.
  • Analytical chemistry and chromatographic techniques.
  • Statistical process analysis.
  • Knowledge of NOM‑059, NOM‑073, and Good Laboratory Practices.

Questions fréquentes

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Published 4 weeks ago

Expires 1 month from now

30 views · 0 interested

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PiSA Farmacéutica

Kumarsain