Head of Quality Control - Pharmaceutical Industry

Description

Position Summary: Lead and comprehensively manage the Physical-Chemical, Microbiological, and Raw Materials Quality Control departments, ensuring compliance with regulations and standards. Key Highlights: 1. Lead and manage the Quality Control department in a pharmaceutical laboratory. 2. Ensure regulatory compliance and quality standards. 3. Supervise analyses, manage teams, and develop personnel. Position Objective Lead and comprehensively manage the Physical\-Chemical, Microbiological, and Raw Materials Quality Control departments, 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, consumables, packaging materials, semi-finished 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 analytical method transfers from Development. Plan laboratory activities based on production needs and regulatory priorities. Coordinate maintenance, qualification, and validation of critical equipment (HPLC, UV, IR, GC). Manage budget, forecast consumables, and propose area investments. Lead, develop, and evaluate the Quality Control team. Ensure initial and ongoing personnel 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 during 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 Head of Quality Control 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 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 focus on quality and regulatory compliance. Analytical ability and planning skills. Effective communication and collaborative work. Adaptability to highly regulated environments.