Sreelakshmi P J

Executive, Quality Assurance

Biocon Biologics Ltd

Bangalore

11.2021 - Current

Responsible for handling of Market Complaints, Quality Related Notifications and Corrective and Preventive Actions
As part of complaint handling, conducted investigations, which involved reviewing batch records, verifying reserve samples, and investigating vendors, all while ensuring that complaints were addressed promptly.
Ensured clear and accurate documentation of all investigative activities and results, and maintained proper file records in accordance with established procedures.
Reviewed and approved the implementation of Corrective and Preventive Actions (CAPAs) across multiple departments, which involved risk assessments, procedural revisions, and evaluating the effectiveness of implemented actions.
Independently faced audits and liaised for US FDA, EMA, ANVISA, INVIMA and other regulatory bodies.
Ensured proper review and timely closure of Corrective and Preventive Actions (CAPAs) initiated as part of such audits or inspections.
Effectively communicated complex technical information to cross-functional teams, regulatory bodies, and external stakeholders, resulting in successful resolution of numerous market complaints and timely closure of all related CAPAs
Highly skilled in managing Quality Management System (QMS) elements within the TrackWise system.
Possess expertise in conducting market complaint investigations and have the ability to analyze and resolve underlying issues related to drug products, medical devices, or combination products.
Possess a comprehensive understanding of applicable regulations and guidelines, including those issued by the FDA, EMA, and ICH, and have a demonstrated ability to ensure compliance with these standards.

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