Spearheaded compliance initiatives in response to audit observations, ensuring prompt implementation of Corrective and Preventive Actions (CAPA).Conducted thorough investigations into deviations, non-conformances, and market complaints.Oversaw the release of finished drug products and raw materials using the SAP system.Maintained audit and inspection readiness by conducting internal audits and ensuring shop floor preparedness.

Managed compliance efforts in response to audit observations, ensuring timely CAPA implementation.Led a team in achieving precise and timely batch record compliance.Conducted in-depth investigations into deviations and non-conformance incidents, leading to root cause resolution.Collaborated with cross-functional teams to approve Master Batch Records, streamlining manufacturing and packing processes.

Collaborated with laboratory teams to ensure compliance with regulatory standards.Assisted in investigating deviations and non-conformance incidents, implementing corrective actions.Supported the review and approval of analytical test methods, ensuring accurate product testing.Participated in internal and external audits, providing necessary documentation.

Led and mentored quality professionals, fostering continuous improvement.Managed batch manufacturing and packing records, ensuring accuracy and compliance.Coordinated regulatory audits, ensuring consistent compliance with various requirements.Developed and delivered training programs on quality management and regulatory compliance.

Conducted comprehensive process and cleaning validation activities, ensuring product quality and regulatory compliance.Collaborated closely with R&D teams to facilitate the transfer of new products from development to commercial manufacturing.Led internal audits and self-inspections, implementing corrective measures to improve processes.

Conducted rigorous quality control tests on raw materials and finished products to ensure compliance with specifications.Collaborated with R&D to validate analytical methods, enhancing testing accuracy.Led investigations into out-of-specification results, implementing corrective actions.

Conducted meticulous testing and analysis of raw materials using advanced laboratory techniques.Ensured strict adherence to quality standards, maintaining overall product integrity.Developed precise Standard Testing Procedures (STP) for raw materials.