*Coordinador de Validación y Transferencias Analíticas

Company: Lupin

Location: CMX, MX

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 appropriate training and competency development programs for chemists.

Qualification and Experience

• Bachelor's degree in: Pharmaceutical Chemistry, Biological Engineering, Pharmaceutical Engineering, or related field.
• Desirable:
  • Diploma in Validation and Applicability of Pharmacopoeial and Non-Pharmacopoeial Analytical Methods.
  • Diploma in Analytical Transfers.
  • Course in the operation of analytical equipment and instruments, Good Documentation Practices (GDP), Good Laboratory Practices (GLP), and Good Manufacturing Practices (GMP).

Skills

• Problem-solving, interpersonal, teamwork, project management, and communication (both oral and written).
• Must be flexible, capable of managing multiple projects simultaneously, and work well under pressure.
• Possess the ability to use sound judgment to handle unforeseen situations with an entrepreneurial attitude and the capacity to conceptualize and implement innovative solutions.
• Be self-motivated and work independently.
• Maintain a service-oriented attitude towards internal clients, constantly devising ways to help them achieve their goals.

Knowledge & Expertise

• Knowledge of pharmacopoeias, FEUM, USP, EMA, BP, and ICH guidelines Q2, Q14, Q10, Q6, Q1, and Q3.
• Knowledge of NOM 059, 241, and 073.
• Knowledge and use of statistical tools.
• Knowledge of laboratory investigations, including aberrant or atypical data.
• Validation of manufacturing processes (desirable).
• Validation of sterilization processes (desirable).