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Stability Chemist
Negotiable Salary
Indeed
Full-time
Onsite
No experience limit
No degree limit
Cam. Real a Cocotitlan 2042, Zona Industrial, 56600 Chalco de Díaz Covarrubias, Méx., Mexico
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Description

We are seeking a Stability Chemist to join Corporativo DL. ### **Position Objective:** Conduct stability studies of raw materials, bulk products, and finished products by performing chemical and physicochemical analytical tests, ensuring compliance with national and international regulations (COFEPRIS, FDA, EMA, ICH, pharmacopoeias). Contribute to determining shelf life, storage conditions, and batch release follow-up. ### **Functions and Responsibilities:** * Perform chemical and physicochemical stability analyses according to approved protocols. * Carry out active ingredient quantification, degradation profiling, potency testing, dissolution, and other applicable tests. * Document results in accordance with Good Documentation Practices (GDP). * Prepare interim and final stability study reports. * Ensure compliance with current ICH guidelines and regulatory requirements. * Monitor the annual stability program. * Operate, calibrate, and maintain analytical equipment (HPLC, UPLC, UV\-Vis, FTIR, dissolution testers, etc.). * Verify proper placement, sampling, and removal from stability chambers. * Collaborate with Production, Analytical Development, Quality Assurance, and Regulatory departments. * Participate in internal and external audits. * Report deviations, OOS (out of specification) results, and support investigations. ### **Required Profile:** * **Education:** Bachelor's degree in Pharmaceutical Chemistry and Biology (QFB), Chemistry, Chemical Engineering, QFI, or related field. * **Experience:** 1–3 years in a quality control or stability laboratory (depending on junior or senior level). * **Knowledge:** * ICH Q1A (R2\), Q1B, Q3B, and applicable NOM regulations. * Proficiency in instrumental techniques (HPLC, GC, UV, FTIR). * Good Manufacturing Practices (GMP) and Good Documentation Practices. * Analytical method validation. ### **Value Proposition:** * Biweekly base salary * + Punctuality bonus + Excellent work environment + Growth opportunities + Statutory benefits Contribute your experience and knowledge to help us maintain and improve our quality standards, contributing to our company’s continued success.

Source:  indeed View original post
Juan García
Indeed · HR

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