Internal Regulatory Affairs Auditor

Description

**We are looking for your talent — join our team at Collins Pharmaceutical Products!** We are a 100% Mexican pharmaceutical company, proudly based in Guadalajara, with over 58 years of experience in the market. We take pride in offering high-quality generic medicines designed to safeguard the health and well-being of Mexicans at fair prices. We are seeking talent like an **INTERNAL AUDITOR WITH EXPERIENCE IN REGULATORY AFFAIRS AND PHARMACOVIGILANCE.** If you possess knowledge in auditing, the pharmaceutical industry, sanitary regulation, pharmacovigilance, NOM-251 and NOM-059, this is your opportunity. It is essential that you have experience in regulatory affairs. **WE OFFER:** * Biweekly salary payments. * 5% savings fund contribution. * Monthly food vouchers amounting to 10% of salary. * 50% vacation bonus. * 30-day year-end bonus (aguinaldo). * Subsidized cafeteria service. * Transportation routes. * Employee purchase discount. **JOB REQUIREMENTS:** * Age: 25 years or older. * Bachelor’s degree in Pharmaceutical Chemistry and Biology, Chemistry, Chemical Engineering, or related fields **(degree certificate mandatory).** * Intermediate English proficiency. * **Proven experience in Regulatory Affairs** ***(minimum 1 year in the pharmaceutical industry).*** * **Proven experience in Pharmacovigilance** ***(minimum 1 year in the pharmaceutical industry).*** * Experience in internal audits, supplier audits, customer audits, API audits, and audits of governmental entities. *(Desirable, less than 1 year required.)* * Knowledge of NOM-059, NOM-251, regulatory affairs, and quality systems. * Proficiency in Microsoft Office and basic ERP systems. * Flexibility in schedule and willingness/ability to travel ***(mandatory).*** * Driver’s license *(desirable).* * Analytical mindset with results orientation. * Communication, negotiation, and leadership skills ***(desirable).*** **FUNCTIONS AND RESPONSIBILITIES:** * Develop and monitor audit programs **(internal, supplier, customer, API, etc.)** to ensure regulatory compliance. * Participate in training sessions for the audit team according to applicable regulations. * Conduct audits in accordance with applicable sanitary regulatory requirements. * Draft and update documents within the Quality Management System (QMS). * Host audits conducted by regulatory authorities and customers. * Follow up on corrective actions arising from audits to ensure continuous improvement and regulatory compliance. **TECHNICAL KNOWLEDGE:** * Intermediate-level Microsoft Office. * Applicable regulations for the pharmaceutical industry and sanitary regulation. * Pharmacovigilance. * Good Manufacturing Practices (GMP) manuals. * Audit reports. * Internal and external audits. * Execution and follow-up of deviations and non-conformities. * API audits. * Labeling and dossier assembly. * MCR (Master Control Record). * COFEPRIS procedures. Working hours: Monday to Friday, 08:00–17:00 hrs. Flexibility in schedule and willingness/ability to travel **(mandatory).** The primary work location is directly at our plant in Zapopan: Av. López Mateos Sur #1938, Col. Agua Blanca Sur, 45235 Zapopan, Jal. *At Grupo Collins, all recruitment processes are free of charge and conducted exclusively through our official channels and platforms: OCC, Computrabajo, Indeed, Facebook, and LinkedIn.* Employment type: Full-time Salary: $22,348.00 per month Benefits: * Transportation assistance or service * Savings fund * Discounts and preferential pricing * Company parking * Option for indefinite-term contract * Cafeteria service * Food vouchers Application question(s): * Do you hold your professional degree? Experience: * Audits: 1 year (Desirable) Willingness to travel: * 50% (Desirable) Workplace: On-site employment