Role: QA EBR Technician
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
Comply with the GMP standards for medicinal and combination products for human use.
Review, control and ensure compliance of Electronic Batch Records (EBR)
and related manufacturing documentation in accordance with internal procedures, GMP rules and Authority and customers requirements, ensuring data integrity, traceability, accuracy and completeness of batch documentation prior to batch disposition and/or release activities.
Specific Responsibilities
· Develop standard operating procedures (general quality and departmental) related to batch record review, good documentation practices and electronic batch record management to ensure that all steps are properly defined and comply with internal and external regulations applicable in each case.
· Review and approve internal SOPs related to EBR management, documentation review and GMP documentation practices.
· Review Electronic Batch Records and associated manufacturing documentation to ensure completeness, accuracy, consistency and compliance with approved procedures and manufacturing instructions.
· Verify that all critic
📌 QA EBR Technician (León)
🏢 Chemo
📍 León