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Quality Control Manager - Pharmaceutical Sector
Negotiable Salary
Indeed
Full-time
Onsite
No experience limit
No degree limit
Av. Bartolomé Mitre 510, B1870AAS Cdad. Autónoma de Buenos Aires, Argentina
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Description

Position Objective To lead and comprehensively manage the Physical-Chemical, Microbiological, and Raw Materials Quality Control area, ensuring compliance with current regulations and quality, traceability, and analytical reliability standards. To guarantee the safety, efficacy, and stability of released products, both oncological and general. Main Responsibilities Supervise and approve/reject raw materials, supplies, packaging materials, semi-finished and finished products (batch records and system). Ensure correct execution of physical-chemical, microbiological, environmental, and process analyses according to GMP and ANMAT requirements. Manage reserve samples and the Master Stability Plan. Coordinate transfer of analytical techniques 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, 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. Actively collaborate with Production, QA, Validation, Development, Procurement, and Regulatory Affairs. 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. We seek a candidate with solid technical education, operational leadership experience, and comprehensive professional judgment, capable of coordinating and supervising Quality Control department activities, ensuring compliance with quality standards, current regulations, and providing technical support to various organizational areas. 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 orientation toward quality and regulatory compliance. Analytical ability and planning skills. Effective communication and collaborative teamwork. Adaptability to highly regulated environments.

Source:  indeed View original post
Sofía González
Indeed · HR

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