Haritha Cherukuru

Quality Assurance Supervisor

Divis Laboratories Limited

09.2019 - 07.2022

Applied knowledge of pharmaceutical manufacturing technologies, FDA and other applicable GMP regulations for pharmaceutical manufacturing
Managed QA aspects of cGMP manufacturing project by acting as QA Representative and worked on issues critical to quality
Reviewed and approved Quality Management System (QMS) documents related to multiple projects, including SOPs, Material and Product Specifications, Master Production Records, Validation Protocols and Reports
Maintained documentation including audit reports, SOPs, regulatory documents, and batch records
Managed document life cycle including, including issuing templates, reviewing, and revising documentation, and routing documents for approval and qualification
Oversaw change controls, CAPAs, deviations, investigations, and validation activities
Responsible for development and maintenance of quality programs, systems, processes, and procedures that ensure compliance with policies and that performance and quality of services conform to established internal and external standards and guidelines
Supported audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of audits
Identified opportunities for Quality continuous improvement of manufacturing practices based on risk approach
Collaborated with Engineering and RA to support product / line changes, ensure compliance aspects associated to validation and risk management activities
Collaborated with manufacturing to help identify root cause, corrections in case of non-conformance
Promoted change control process, risk management tools and CAPA process as prevention drivers in manufacturing activities
Prepared reports and necessary documentation (Corrective and Preventative Actions) and provided to applicable stakeholders, both internal and external
Initiated, reviewed, and updated Quality Manual and Standard Operating Procedures and Change Control implementation processes
Developed, implemented, and provided recommendations of Quality Management Systems documents such as Standard Operating Procedures per Quality policies and procedures per local regulatory requirements
Responsible for maintaining and tracking quality systems documentation and requests in accordance with regulatory requirements and internal processes
Initiated, coordinated, and participated in review and recommendations of CAPAs, Deviation, data and documentation reviews and analysis reporting in response to procedural or regulatory commitments
Evaluated and ensured effectiveness of corrective and preventative actions
Provided support to supplier's quality system improvements
Assisted suppliers in implementation and performance of process validation activities
Managed internal/external supplier quality related projects