Role: QA Technical Department
Location: León
Experience: 1–3 years.
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INSUD PHARMA operates across the entire pharmaceutical value chain, providing specialist knowledge and expertise in scientific research, development, manufacturing, sales and marketing of a wide range of active pharmaceutical ingredients (APIs), finished dosage forms (FDFs) and branded pharmaceutical products, adding value to human and animal health.
INSUD PHARMA’s activities are organised into three synergistic business areas: Industrial (Chemo), Branded (Exeltis) and Biotechnology (mAbxience), with over 9,000 professionals in more than 50 countries, 20 state-of-the-art facilities, 15 specialised R&D; centres, 12 sales offices and more than 35 pharmaceutical subsidiaries, serving 1,150 customers in 96 countries worldwide. INSUD PHARMA believes in innovation and sustainable development.
Integral Responsibility
Suppliers compliance and Management of quality technical agreements in accordance to internal procedures, GMPs rules, Authorities and customers requirements. EU & US GMP compliance.
Assure compliance of GMP, regulatory and internal standards according to quality policies and applicable requirements within the organization.
Specific Responsibilities
Review, negotiate and manage Quality Technical Agreements with customers, suppliers & third parties and services.
Supplier’s qualification management: risk analysis performance, register update, annual audit plan preparation and follow up, evaluation of the documental compliance, approval and certification status follow up, supplier status update on SAP system.
Receipt, filling and delivery to customers of quality questionnaires to be filled by QA.
ICH Q3D and nitrosamine reports review and management
Elaborate and follow-up self-inspections program and conduct self-inspections.
Support and external audits and inspections according to assess the quality of the GMP system.
Develop standard operating procedures (general quali
📌 QA Technical Department (León)
🏢 Chemo
📍 León