Karuna P

Assistant Manager

Sai Life Sciences Ltd

01.2013 - Current

▪ Prepared comprehensive batch records, detailing manufacturing steps, equipment usage, raw material specifications, and quality control tests performed for each production batch.
▪ Collaborated with production teams to gather data and generate accurate and complete campaign reports, summarizing production activities, including batch yields, deviations, and quality control results.
▪ Developed and revised standard operating procedures (SOPs) for various production processes, ensuring compliance with regulatory requirements and industry best practices.
▪ Implemented document control processes within Quality Management System (QMS), including document creation, revision, approval, distribution, and archival.
▪ Conducted internal audits of production documentation to assess compliance with SOPs, regulatory guidelines, and quality standards. Identified areas for improvement and implemented corrective actions.
▪ Prepared and maintained validation documentation, including validation protocols, reports, and risk assessments, to ensure qualification and validation of production equipment and processes.
▪ Supported change control processes by documenting and managing changes to production processes, equipment, and materials. Ensured proper review, approval, and implementation of change requests.
▪ Acted as a point of contact and subject matter expert for production documentation during regulatory inspections and audits and customer audits, ensuring all required documents were readily accessible and in compliance with cGMP guidelines.
▪ Trained and educated production personnel on proper documentation practices, including the importance of accurate data recording, following SOPs, and maintaining traceability.
▪ Implemented electronic document management systems (EDMS) to enhance the control, storage, retrieval, and archival of production documentation. Trained users on the DMS and provided ongoing support.
▪ Actively monitored industry trends and regulatory updates related to production documentation, ensuring ongoing compliance and implementing necessary changes and updates.
▪ Utilized electronic document management systems (DMS) to streamline document control processes and improve the handling of production documentation.
▪ Implemented and managed the DMS to ensure efficient document storage, retrieval, version control, and distribution.
▪ Uploaded and maintained production documentation within the DMS, including batch records, SOPs, work instructions, and forms.
▪ Established metadata and indexing strategies within the DMS to facilitate easy search and retrieval of production documents, saving time and improving efficiency.
▪ Implemented workflows and approval processes within the DMS to ensure proper review, approval, and distribution of production documentation.
▪ Trained production personnel on the use of the DMS, providing guidance on document uploading, versioning, and retrieval.
▪ Actively monitored the performance and usability of the DMS, identifying opportunities for system enhancements or upgrades to improve efficiency and user experience.
▪ Utilized the electronic applications like GMP Pro, Document management system (DMS) and Audit management system (AMS) to support customer inspections and audits, ensuring that all required production documents were readily accessible, properly controlled, and compliant with regulatory guidelines.
▪ Conducted investigations and prepared thorough investigation reports for deviations, non-conformances, and quality incidents related to production processes. Identified root causes, implemented corrective actions, and documented the findings in the investigation reports.
▪ Collaborated with cross-functional teams to gather information and evidence during investigations, ensuring a comprehensive understanding of the issues and their impact on production documentation.
▪ Worked closely with the Quality Assurance team to ensure that investigation reports were accurately documented, aligned with regulatory requirements, and addressed any potential risks to product quality and patient safety.
▪ Participated in cleaning validation activities by developing and executing cleaning validation protocols, ensuring that the cleaning processes effectively remove residues and maintain cleanliness standards.
▪ Prepared cleaning validation reports, documenting the validation results, including acceptance criteria, analytical methods, sampling procedures, and equipment specifications.
▪ Collaborated with the Quality Control team to ensure appropriate sampling and testing of cleaned equipment to verify the effectiveness of the cleaning process.
▪ Implemented document control processes for investigation reports and cleaning validation documents, ensuring proper review, approval, and archiving in compliance with regulatory requirements.
▪ Utilized electronic document management systems (DMS) to manage and store investigation reports and cleaning validation documents, facilitating easy access, retrieval, and traceability.
▪ Assisted in the evaluation and implementation of corrective and preventive actions (CAPAs) resulting from investigations and cleaning validation activities, ensuring long-term resolution and prevention of recurrence.
▪ Provided support during regulatory inspections and customer audits by presenting investigation reports and cleaning validation documentation to regulatory authorities, demonstrating compliance with cGMP guidelines and regulatory requirements.

Summary

Overview

Work History

Assistant Manager

Education

M.Sc. - Chemistry

B.Sc. - Chemical technology

Intermediate -

SSC -

Skills

Timeline

Assistant Manager

M.Sc. - Chemistry

B.Sc. - Chemical technology

Intermediate -

SSC -

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