Analista de Documentação Técnica Pl (Controle de Qualidade) - Barueri/SPJoin us at Daiichi Sankyo Brasil Ltda, a Japanese pharmaceutical company committed to improving global quality of life through innovative medicines.
We foster a culture of collaboration, trust, and inclusion, valuing diverse talents and perspectives.Responsibilities and duties:Develop, review, and implement analytical methods, specifications, and GAP analyses for materials such as raw materials, packaging materials, products, and stability studies.Establish and maintain operational procedures for analytical equipment (physical-chemical and microbiological).Manage schedules for method, specification, and SOP expirations.Interpret, discuss, and investigate quality control test results to support decision-making.Support quality investigations related to out-of-specification results, market complaints, and deviations.Investigate and document quality deviations related to technical documentation.Implement corrective and preventive actions (CAPA).Draft and review SOPs, user requirement specifications, analytical specifications, and other documents in compliance with Good Manufacturing Practices.Participate in audits and provide clarifications during national and international inspections.Research technical-scientific material from various sources to support activities.Assist with documentation for routine laboratory activities, including validation, stability studies, and quality control.Identify operational improvement opportunities for documentation management.Contribute to continuous improvement and knowledge retention within the department.Conduct technical training sessions and participate in qualification processes.Ensure the integrity and proper functioning of equipment, systems, and facilities under your responsibility.Qualifications:Bachelor's degree in Pharmacy, Chemistry, Chemical Engineering, or related fields.Proficiency in reading and writing in English.Intermediate Spanish is desirable.Proficiency in MS Office tools.Knowledge of ERP systems such as SAP, PUG, and LIMS is a plus.Experience in Quality Control or laboratory settings.Familiarity with pharmacopeias.Registration with the professional council is required.Additional information:We offer benefits including meal and food vouchers, medical and dental assistance, TotalPass, pharmacy partnership, and private pension plan.Get notified about new Documentation Analyst jobs in Barueri, São Paulo, Brazil.
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