Senior Manufacturing Operator

Description

Job Summary: Ensure the manufacturing of solid and liquid pharmaceutical products in strict compliance with regulatory requirements and guaranteeing a continuous supply of effective and safe medications. Key Highlights: 1. Solid and liquid pharmaceutical product manufacturing 2. Ensuring quality and safety standards for medications 3. Strict compliance with regulations and procedures **The Position** --------------- The purpose of this position is to ensure the manufacturing of solid and liquid pharmaceutical products in strict compliance with Mexican regulatory requirements and those of the countries to which our products are exported. Additionally, it ensures the correct application of current internal procedures and policies, guaranteeing a continuous supply of products fully adherent to quality standards that deliver effective and safe medications to our patients. **Tasks and Responsibilities** ------------------------------ * Execute assemblies, format changes, and equipment preparation according to established procedures. * Maintain, execute, and improve operational and autonomous maintenance standards, including compliance with corresponding documentation. * Perform in-process controls in accordance with current guidelines. * Document all activities following instructions in the internal document (DI) in the relevant records. * Execute area and equipment cleaning, as well as necessary clearances to ensure absence of cross-contamination in processes. * Ensure proper identification and segregation of products, guaranteeing traceability of each batch until its transfer to the next process stage. * Adhere to operational standards to meet process times per the production plan for each shift, ensuring availability of required materials (preparation, minor and major format changes, cleaning, and operation). * Assume personal responsibility and promote appropriate use of personal protective equipment (PPE) by the work team according to the process being performed. * Immediately report any identified unsafe condition or act, with the objective of preventing accidents and maintaining a safe working environment. **Requirements** : **Mandatory** * Possess a high school diploma or equivalent. * Have at least two years of experience in coating operations, including coating drums (manual, semi-automatic, automatic). * Possess knowledge of Good Manufacturing Practices (GMP) and manufacturing systems such as TPM, WCM, and Lean Manufacturing. **Desirable** * Proficient computer skills (SAP, MES).