Descripción de la oferta
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.
Global 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 critical process steps, controls, calculations, material reconciliations and manufacturing data are correctly documented in the EBR system and related records.
· Ensure that all entries, corrections, comments and changes in the electronic records are properly documented and compliant with data integrity and GMP requirements.
· Manage discrepancies identified during batch record review and coordinate with Production and other involved departments their investigation, correction and closure in accordance with internal procedures.
· Support root cause analysis and trend analysis related to documentation errors, batch record discrepancies and recurring issues detected during EBR review.
· Coordinate with Production, Engineering, Maintenance, Validation and other departments to ensure that any issue impacting batch documentation is properly assessed and resolved.
· Review and verify that deviations, change controls or other quality events impacting the batch are properly linked, assessed and documented in the batch record package when applicable.
· Ensure the proper management, traceability and archive of GMP documentation related to batch manufacturing records.
· Support the implementation, maintenance and continuous improvement of electronic batch record systems and associated documentation workflows.
· Participate in training activities related to Good Documentation Practices, GMP requirements and proper use/completion of Electronic Batch Records.
· Support external audits and inspections according to the Annual Plan to assess compliance of batch documentation practices, data integrity requirements and the GMP system.
· Participate in internal audits related to documentation practices, EBR processes and manufacturing records.
· Support the Qualified Person and batch release activities through timely and accurate review of manufacturing documentation.
· Support on quality investigations, batch documentation assessments and product quality issues related to manufacturing records.
· Support to quality activities according to the appropriate training.
Competencies/Career level
Innovation, customer oriented, communication, team work, adaptability/flexibility, productivity, self-development, sense of urgency, initiative.
Attention to detail, analytical mindset, compliance mindset, documentation rigor and organizational skills are especially valuable for this position.
Requirements and personal skills
· Education: Degree in Pharmacy or Chemistry or Sciences.
· Languages: Intermediate or high level of English and bilingual in Spanish.
· Experience (years/area): A minimum of 3 years' experience in similar position for a senior position. Experience in GMP documentation review, manufacturing records, batch record review or pharmaceutical production quality activities is highly valuable.
· Specific Knowledge: Knowledge of GMP documentation systems, good documentation practices, batch record review processes, deviations/non-conformities, data integrity principles and quality systems in production plants. Experience with Electronic Batch Records (EBR) systems will be highly valued.
· Travels: Not required.
· Personal skills: Good communication skills, proactivity, good working under pressure, team working, problem-solving, good organizational skills, persistence and high attention to detail.
COMMITMENT TO EQUAL OPPORTUNITIES
The InsudPharma Group recognises that business management must be aligned with the needs and demands of society, and therefore is committed to equal opportunities and equal treatment for men and women, as set out in the relevant legislation in force – Organic Law 3/2007 – and we do not discriminate against anyone on the grounds of ethnicity, religion, age, sex, nationality, marital status, emotional or sexual orientation, gender identity or expression, disability, or any other personal or social circumstance.
