Analista Químico de Métodos Analíticos | Validación GMP

Pfizer; México; Vor Ort; MXN 480.000 - 640.000; Vollzeit

Zusammenfassung

Pfizer Mexico seeks a qualified professional to lead analytical method validation activities within GMP-regulated labs. You will plan, execute, and document validation and verification for chemical and physicochemical methods, ensuring data integrity and compliance with regulatory expectations.

You'll collaborate across Quality, Regulatory, Manufacturing, and R&D teams to support method transfers, deviations, and lifecycle management, maintaining inspection-ready records and robust training

Qualifikationen

• Bachelor's degree in Chemistry/Pharmaceutical Sciences, Chemical Engineering, Biology, Biochemistry, or related scientific discipline with GMP lab experience (4 years).
• Experience supporting analytical method validation, verification, transfer, or lifecycle activities for chemical/physicochemical methods.
• Ability to interpret validation protocols, compendial procedures, SOPs, and regulatory expectations.
• Knowledge of GMP, GLP, data integrity, lab documentation, and quality systems for analytical testing.
• Ability to organize validation activities, manage priorities, and maintain inspection-ready records.
• Strong written and verbal communication to document results and discuss method issues with stakeholders.
• Proficiency with analytical instruments and CDS/quality systems including data entry and review.
• Intermediate English level for reading and drafting technical documents.

Aufgaben

• Plan and execute analytical method validation activities as per approved protocols.
• Prepare samples, standards, reagents, and documentation for validation studies.
• Execute validation tests (specificity, accuracy, precision, linearity, range, robustness, system suitability, LOD/LOQ).
• Ensure training records reflect qualification to perform validation/verification.
• Verify instrument readiness, calibration, and system suitability before testing.
• Evaluate validation data against acceptance criteria and perform trend analysis.
• Maintain validation documentation and compliance with GMP/GLP and data integrity.
• Document results in computerized systems and support workflows; maintain inspection-ready records.
• Support deviations, changes, and method transfers; lifecycle management activities.

Kenntnisse

Analytical method validation

Documentation

Instrument proficiency

Cross-functional collaboration

English writing/reading

Ausbildung

Bachelor's degree in Chemistry/Pharma/related

Tools

Chromatography data systems (CDS)

gLIMS

Electronic notebooks

Document management systems

Quality management systems

Jobbeschreibung

Pfizer Mexico seeks a qualified professional to lead analytical method validation activities within GMP-regulated labs. You will plan, execute, and document validation and verification for chemical and physicochemical methods, ensuring data integrity and compliance with regulatory expectations.

You'll collaborate across Quality, Regulatory, Manufacturing, and R&D teams to support method transfers, deviations, and lifecycle management, maintaining inspection-ready records and robust training