D*************l

•Managed end-to-end creation, review, and approval of quality-related documents including Batch Manufacturing Records (BMRs), Batch Packaging Records (BPRs), and stability study documentation in compliance with Schedule M GMP guidelines. •Executed 200+ in-process quality control tests (disintegration, moisture content, hardness, friability) with zero batch rejections attributable to quality failures, demonstrating robust IPQA oversight. •Directed GMP-compliant manufacturing operations across granulation, blending, compression, coating, and filling, ensuring product consistency and compliance throughout all process stages. •Authored, reviewed, and updated Standard Operating Procedures (SOPs) and product specifications to align with corporate quality standards and regulatory requirements (Schedule M, GMP). •Led QA change control initiatives, CAPA implementation, and deviation resolution, reducing deviation closure time and improving compliance tracking across the facility. •Conducted risk assessments (FMEA methodology) and implemented corrective and preventive actions (CAPAs) to address process deviations and maintain continuous GMP compliance. •Accelerated artwork verification and incoming material inspection workflows, reducing packaging defects by 40% and improving supplier quality alignment. •Revamped in-process quality assurance (IPQA) protocols, boosting IPQA effectiveness by 30% through systematic procedural improvements and cross-functional training. •Participated in internal self-inspections and regulatory audit readiness activities, supporting timely closure of audit observations. •Maintained controlled documentation for plant equipment qualification, calibration records, and GMP-relevant workflow implementation.

•Supported QA team in preparing and reviewing GMP-compliant documentation for regulatory audits and submissions, gaining exposure to large-scale pharmaceutical compliance operations. •Gained hands-on experience in batch record handling, GMP documentation control, and change control procedures within a regulated manufacturing environment. •Assisted in monitoring deviations, CAPA tracking, and change control workflow to ensure continuous regulatory compliance.