Quality Control Manager – Pharmaceutical Industry

Description

Job Summary: Lead and manage physical-chemical, microbiological, and raw material quality control to ensure regulatory compliance and quality standards for pharmaceutical products. Key Highlights: 1. Lead and comprehensively manage the Quality Control department. 2. Ensure product quality, traceability, and analytical reliability. 3. Participate in internal audits, regulatory inspections, and customer audits. Job Objective To lead and comprehensively manage the physical-chemical, microbiological, and raw material Quality Control department, ensuring compliance with current regulations and quality, traceability, and analytical reliability standards. Guarantee the safety, efficacy, and stability of released products, both oncological and general. Main Responsibilities Supervise and approve/reject raw materials, supplies, packaging materials, intermediate and finished products (batch records and system). Ensure proper execution of physical-chemical, microbiological, environmental, and process analyses according to GMP and ANMAT requirements. Manage retention samples and the Master Stability Plan. Coordinate transfer of analytical techniques from Development. Plan laboratory activities based on production schedules and regulatory priorities. Coordinate maintenance, qualification, and validation of critical equipment (HPLC, UV, IR, GC). Manage budget, supply forecasting, and propose area investments. Lead, develop, and evaluate the Quality Control team. Ensure initial and ongoing staff training. Lead investigations of Out-of-Specification (OOS), Out-of-Trend (OOT), and analytical deviations. Draft and update procedures, specifications, and instructions. Participate in change controls together with QA and Validation. Represent the department in internal audits, regulatory inspections, and customer audits. Collaborate actively with Production, QA, Validation, Development, Procurement, and International Registration. Evaluate and audit suppliers and third-party laboratories. We are seeking a Quality Control Manager for a pharmaceutical laboratory specializing in conventional and oncological medicines, located in Avellaneda. Requirements Education University degree in Pharmacy, Biochemistry, or related fields. Experience Minimum 3 years’ experience in Quality Control laboratories within the pharmaceutical industry. Technical Knowledge GMP, GLP, ANMAT, USP, Ph. Eur., ICH. Analytical techniques (HPLC, UV, IR, GC) and microbiological methods. Analytical method validation. OOS/OOT and stability management. Tools Advanced Excel. Document management systems. Desirable experience with LIMS and/or ERP. Languages Intermediate/advanced technical English. Competencies Technical leadership and team management. Strong quality and regulatory compliance orientation. Analytical ability and planning skills. Effective communication and collaborative teamwork. Adaptability to highly regulated environments.