**Coordinador de Validación y Transferencias Analíticas

Job Description

Coordinate the planning and execution of validation/applicability, optimization, and transfer programs for analytical methodologies (pharmacopoeial and non-pharmacopoeial) for new developments, reformulations, and raw materials, both in internal and external national and international laboratories.
Define strategies based on risk analysis, pharmacopoeias, standards, and literature.
Review and approve protocols and reports, ensuring compliance with GLP, GDP, and GMP, as well as the proper execution by the personnel in charge.
Manage material resources, equipment, and supplies, guaranteeing compliance with the area's programs.
Participate in internal and external audits related to the area.
Provide technical support to formulation, development, production, and quality.
Manage special projects and urgent analytical validation requests.
Prepare and update area documentation in accordance with GLP, GDP, and GMP.
Ensure the planning and execution CAPEX process, calibration, maintenance, and qualification programs for equipment in coordination with internal areas and suppliers. Ensure the training of staff under your supervision.
Maintain and report project and operational dashboards (scope, responsible party, milestones, dates, and status) to management and leadership.
Ensure appropiate training and competency development programs for chemists

Qualification and Experience

Bachelor's degree in: Pharmaceutical Chemistry, Biological Engineering, Pharmaceutical Engineering, or related field
Desirable:
1) Diploma in Validation and Applicability of Pharmacopoeial and Non-Pharmacopoeial Analytical Methods.

2) Diploma in Analytical Transfers.

3) Course in the operation of analytical equipment and instruments, Good Documentation Practices (GDP), Good Laboratory Practices (GLP), and Good Manufacturing Practices (GMP).

Skills:

a) Problem-solving, interpersonal, teamwork, project management, and communication (both oral and written).

b) Must be flexible, capable of managing multiple projects simultaneously, and work well under pressure.

c) Possess the ability to use sound judgment to handle unforeseen situations with an entrepreneurial attitude and the capacity to conceptualize and implement innovative solutions.

d) Be self-motivated and work independently. e) Maintain a service-oriented attitude towards internal clients, constantly devising ways to help them achieve their goals.

a) Knowledge of pharmacopoeias, FEUM, USP, EMA, BP, and ICH guidelines Q2, Q14, Q10, Q6, Q1, and Q3.

b) Knowledge of NOM 059, 241, and 073.

c) Knowledge and use of statistical tools.

d) Knowledge of laboratory investigations, including aberrant or atypical data.

e) Validation of manufacturing processes (desirable).

f) Validation of sterilization processes (desirable).

Competencies