Analytical Method Validation Specialist

Pfizer; Toluca; Presencial; MXN 400.000 - 700.000; Jornada completa

Descripción de la vacante

Pfizer Mexico's Toluca site is seeking a qualified analyst to support analytical method validation and lifecycle activities in a GMP-regulated lab. You will prepare samples, run validation tests, and ensure data integrity and documentation align with quality standards.

Strong communication, English proficiency, and experience with analytical instruments and data systems are essential to collaborate across Quality, Regulatory, and Manufacturing teams.

Formación

• Bachelor's degree in Chemistry or related field with GMP laboratory exposure.
• 4 years of GMP lab experience in analytical method validation or related area.
• Ability to interpret protocols, SOPs, and regulatory expectations.
• Working knowledge of GMP, data integrity, and lab documentation.

Responsabilidades

• Support analytical method validation activities per approved protocols.
• Prepare samples, standards, reagents, and documentation for validation.
• Execute validation tests such as specificity, accuracy, precision, linearity, range, robustness, system suitability, LOD/LOQ, and method equivalency.
• Ensure training records reflect qualification to perform validation and verification.
• Verify instrument readiness and system suitability before testing.
• Evaluate validation data against predefined acceptance criteria and trends.
• Ensure compliance of documentation with GMP/LAB practices and data integrity.
• Document and report results in computerized systems and support workflows.
• Support investigations, deviations, change controls, and method transfers.

Conocimientos

Analytical method validation

Data integrity

Documentation & records management

Strong communication

English proficiency (Intermediate)

Educación

Bachelor's degree in Chemistry / Pharmaceutical Sciences / related field

4 years GMP laboratory experience

Herramientas

Chromatography data systems

gLIMS

Electronic notebooks

Document management systems

Quality management systems

Descripción del empleo

Pfizer Mexico's Toluca site is seeking a qualified analyst to support analytical method validation and lifecycle activities in a GMP-regulated lab. You will prepare samples, run validation tests, and ensure data integrity and documentation align with quality standards.

Strong communication, English proficiency, and experience with analytical instruments and data systems are essential to collaborate across Quality, Regulatory, and Manufacturing teams.