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Development Analyst
MXN 12,500/year
Indeed
Full-time
Onsite
No experience limit
No degree limit
C. Benito Juárez García 20, Zona Centro, 37980 San José Iturbide, Gto., Mexico
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Description

**Position Objective:** The Development Analyst is responsible for conducting tests and developing analytical methodologies, as well as executing protocols from method validation to analytical method transfer to comply with NOM-059-SSA1-2015. Similarly, this role ensures compliance with NOM-073-SSA1-2015 by monitoring the annual stability program, including accelerated and long-term stability studies. Additionally, the analyst participates in compiling dossiers containing stability studies and analytical methodology validations. **Education Required**: Bachelor's degree in Pharmaceutical Chemistry and Biology, Chemistry, or related field. **Key Job Responsibilities:** * Mastery of NOM-059-SSA1-2015 and NOM-073-SSA1-2015 regulations. * Participate in dossier preparation for new product registrations. * Perform analysis of materials (excipients, active pharmaceutical ingredient, primary packaging), bulk product, in-process product, and finished product for products under development and stability studies. Generate corresponding evidence of performed analyses. * Operate high-precision analytical instruments (HPLC, GC, IR, etc.). * Ensure adherence to good laboratory practices and documentation standards. * Conduct analytical method validation tests, stability analyses, impurity testing, and dissolution profiling. * Execute stability studies and maintain finished products under optimal storage conditions within stability chambers. * Knowledge of handling, properties, and characteristics of reagents and solutions. **Functional Competencies:** 1. Laboratory work. 2. General physicochemical analysis. 3. Handling and knowledge of Pharmacopoeias (FEUM, USP, EP). 4. Development of standard operating procedures. 5. Operation of analytical instrumentation. **Minimum Required Experience Areas** * Experience working in an analytical laboratory. * Operation of HPLC equipment. * Operation of gas chromatographs. * Application of analytical techniques. * Laboratory area knowledge. Job Type: Full-time, Indefinite duration Salary: Starting at $12,500.00 per month Benefits: * Salary increases * Opportunity for indefinite contract * Subsidized cafeteria service * Grocery vouchers Work Location: On-site employment

Source:  indeed View original post
Juan García
Indeed · HR

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