Químico Analista de Soporte Analítico (Posicion Temporal
- 12 meses)### Químico Analista de Soporte Analítico (Posicion Temporal
- 12 meses)Solliciteren: Mexico
- Toluca: Voltijds: Gisteren geplaatst: 4967210# Use Your Power for Purpose Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our adaptable, innovative, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance, or research analysis, your contributions have a direct impact on patient care. By being part of our team, you help uphold a quality culture that adapts and evolves to meet the needs of patients, ensuring that every product we deliver is of the highest standard. # What You Will Achieve In this role, you will:
* Support the planning and execution of analytical method validation activities for chemical and physicochemical methods in accordance with approved protocols.
* Prepare and organize samples, standards, reagents, solutions, reference materials, and documentation required for validation studies.
* Execute validation tests such as specificity, accuracy, precision, linearity, range, robustness, system suitability, detection limit, quantitation limit, and method equivalency, as applicable.
* Ensure training records reflect current qualification to perform validation, verification, and routine analytical method activities.
* Verify instrument readiness, calibration status, analytical conditions, and system suitability requirements before executing validation or verification testing.
* Evaluate validation data for compliance with predefined acceptance criteria, including statistical assessment, trend evaluation, and investigation of atypical or out-of-specification results.




* Ensure validation documentation, raw data, calculations, protocols, reports, and quality records comply with Good Manufacturing Practices, Good Laboratory Practices, data integrity expectations, and applicable procedures.
* Document and report validation results in computerized systems, perform data entry and review, support approval workflows, and maintain inspection-ready records.
* Support investigations, deviations, change controls, method transfers, and continuous improvement initiatives related to analytical method lifecycle management. # Here Is What You Need (Minimum Requirements)
* Bachelor's degree in Chemistry, Pharmaceutical Sciences, Chemical Engineering, Biology, Biochemistry, or a related scientific discipline with relevant experience in a GMP-regulated laboratory with 4 years of relevant experience.
* Demonstrated experience supporting or executing analytical method validation, verification, transfer, or lifecycle activities for chemical or physicochemical methods.
* Ability to interpret analytical methods, validation and verification protocols, compendial procedures, Standard Operating Procedures, technical procedures, and applicable regulatory expectations.
* Working knowledge of Good Manufacturing Practices, Good Laboratory Practices, data integrity principles, laboratory documentation requirements, and quality systems applicable to analytical testing.




* Ability to organize validation and verification activities, manage multiple priorities, follow approved timelines, and maintain complete, accurate, and inspection-ready records.
* Strong written and verbal communication skills to document technical results, summarize conclusions, support investigations, and communicate method-related issues to cross-functional stakeholders.
* Proficiency with analytical laboratory instruments and computerized systems used for method validation and verification, including appropriate instrument checks, system suitability evaluation, data entry, review, and interpretation.
* Intermediate English level, for reading and drafting technical documents # Bonus Points If You Have (Preferred Requirements)
* Hands-on experience executing or supporting analytical method validation, verification, transfer and lifecycle management for pharmaceutical products, raw materials, or components.
* Experience with analytical validation techniques such as HPLC, GC, UV-Vis, dissolution, Karl Fischer/water determination, residual solvents, impurity testing, assay, identification, viscosity and particle size analysis.
* Strong understanding of validation parameters, statistical tools, acceptance criteria, data trending, system suitability, and risk-based evaluation of analytical method performance.
* Familiarity with applicable regulatory and compendial expectations, including ICH, USP, EP, JP, or local health authority guidance related to analytical method validation and verification.
* Experience drafting, reviewing, or approving validation and verification protocols, reports, analytical procedures, technical assessments, deviations, investigations, and change controls.
* Experience using laboratory computerized systems such as chroma

📌 Químico Analista de Soporte Analítico (Toluca de Lerdo)
🏢 Pfizer
📍 Toluca de Lerdo