Chaithanya P.

Reviewed and executed study protocols and final reports of PQ.

• Enhanced protocol and cGMP adherence.
• Lead Batch Manufacturing Record and Quality Management Systems (QMS) implementation in drug Product facilities & logbooks reviews.
• Maintained accurate records of activities, initializations, and deviations from expected results.
• Maintained a strong understanding of regulatory requirements ( e.g : Amneal , DRLAbbott) and proficiency in equipment and system validation through documentation and reporting skills.
• Process analysis in manufacturing, filling optimization. Attention to the details and compliance with specified software ICADS.
• Performed regular reviews of existing documents to identify areas for improvement or update outdated information.
• Attended US FDA audits and compliance checks to uphold stringent regulatory standards.
• Prepared alarm trend reports for equipment in respective areas to ensure operational efficiency.
• Basic knowledge in the SAP system.
• Foster a culture of quality and safety within the organization through proactive measures and continuous improvements initiatives.
• Basic knowledgeable in formulation, filtration & filling area.
• Assisted in compiling technical documents
• Performed batch record review BMR/BPR review, and ensured timely closure of documentation gaps for batch release
• Documentation handling for the fill finish manufacturing including preparation and review of BMR, BPR, Study protocols etc
• Responsible for timely initiation and closure of QMS elements
• Preparing, Planning and coordinating for regulatory, customer and internal audits
• Responsible for review of executed BMR/BPR and logbooks in Fill Finish Manufacturing
• Ensured data integrity compliance (ALCOA) across all documentation activities