About this role
<div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px">Job Description</H2> </div><div><p>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.<br>Define strategies based on risk analysis, pharmacopoeias, standards, and literature.<br>Review and approve protocols and reports, ensuring compliance with GLP, GDP, and GMP, as well as the proper execution by the personnel in charge.<br>Manage material resources, equipment, and supplies, guaranteeing compliance with the area's programs.<br>Participate in internal and external audits related to the area.<br>Provide technical support to formulation, development, production, and quality.<br>Manage special projects and urgent analytical validation requests.<br>Prepare and update area documentation in accordance with GLP, GDP, and GMP.<br>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.<br>Maintain and report project and operational dashboards (scope, responsible party, milestones, dates, and status) to management and leadership.<br>Ensure appropiate training and competency development programs for chemists</p></div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px">Qualification and Experience</H2> </div><div><p>Bachelor's degree in: Pharmaceutical Chemistry, Biological Engineering, Pharmaceutical Engineering, or related field<br>Desirable:<br>1) Diploma in Validation and Applicability of Pharmacopoeial and Non-Pharmacopoeial Analytical Methods.</p> <p>2) Diploma in Analytical Transfers.</p> <p>3) Course in the operation of analytical equipment and instruments, Good Documentation Practices (GDP), Good Laboratory Practices (GLP), and Good Manufacturing Practices (GMP).</p> <p>Skills:</p> <p>a) Problem-solving, interpersonal, teamwork, project management, and communication (both oral and written).</p> <p>b) Must be flexible, capable of managing multiple projects simultaneously, and work well under pressure.</p> <p>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.</p> <p>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.</p> <p>a) Knowledge of pharmacopoeias, FEUM, USP, EMA, BP, and ICH guidelines Q2, Q14, Q10, Q6, Q1, and Q3.</p> <p>b) Knowledge of NOM 059, 241, and 073.</p> <p>c) Knowledge and use of statistical tools.</p> <p>d) Knowledge of laboratory investigations, including aberrant or atypical data.</p> <p>e) Validation of manufacturing processes (desirable).</p> <p>f) Validation of sterilization processes (desirable).</p></div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px">Competencies</H2> </div><div><div>Collaboration</div><div>Customer Centricity</div><div>Developing Talent</div><div>Innovation & Creativity</div><div>Process Excellence</div><div>Result Orientation</div><div>Stakeholder Management</div><div>Strategic Agility</div></div></div></div>