• Planned and prioritized assigned document review workload to meet the requirement.• Ensure that related documents for stability, calibration and analytical development and method validation are reviewed to meet Taro and cGMP requirements. • Review OOT/OOS investigations and assist in establishing the root cause.• Created, reviewed, and wrote SOPs pertaining to the group.• Completed all GMP Documentation correctly and all training assignments.

• Reviewed all R&D group regular technical documents and confirmed data integrity. (e.g., Batch Record, RM, FP, method validation, development and transfer, stability study testing, calibration report).• Reviewed and approved revised change control, SOP, GMP documents, method, and protocols.• Provided technical support and assisted QMS and computerized system with daily operations.• Conducted and reviewed OOS/OOT/DRs investigation generated by laboratory. • Released Product Certificate of Analysis using LIMS and Raw Material & Packaging Components in SAP.• Ensured the test method, protocols and SOPs have been followed by scientist/chemist in compliance with regulatory and global quality policies.• Followed up with scientist /chemists to ensure data integrity and results meet predefined specification. • Notified department supervisor/manager regarding omission, incomplete testing result or other irregularities.• Collaborated and assisted technical writers to complete validation reports as clients’ requirements.• Conducted, coached, and guided chemists in technique and GMP /GLP/ALCOA.

• Improved outputs in document review including lab notebooks, analytical data, batch records, validation documents and instrument calibration certificates to ensure compliance with the regulations.• Reviewed product release documents to verify completeness, correctness, and accuracy.• Conducted lab related work is documented in compliance with date integrity.• Regularly inspected in production process control and package online check.• Standardized SOPs, optimized test methods, updated specifications and followed validation protocols through continuous improvement activities.• Tracked and identified OOS / OOT results, deviations, atypical results, or any issues of non-conformance and carried out investigations.• Reviewed internal procedure and corporate standards, performed gap assessment and updated SOPs accordingly.• Investigated product complaints and ensured the timely closure of records.• Successfully supported compliance functions, projects, inspections, and quality assurance actions such as risk assessment, CAPA.• Actively involved in external & internal audits to ensure meet requirements of quality assurance and control system.

• Significantly improved skill metrics level in the department with through capability and contribution of analyzing raw materials, in-process /finish products, stability, and method validation/development.• Completed a few projects which required method validations and successfully transfer to product.• Efficiently operated, calibrated, maintained laboratory instruments to warranty their accuracy and utilization such as HPLC, GC, FTIR, Vis-UV, ICP, dissolution apparatus, auto-titrator, etc.• Documented comprehensive, accurate and timely experimental observations.• Provided techniques and problem-solving solutions that support troubleshooting complex instrumentation and method problems• Significantly improved skill metrics level in the department with through capability and contribution of analyzing raw materials, in-process /finish products, stability, and method validation/development.• Completed a few projects which required method validations and successfully transfer to product.• Efficiently operated, calibrated, maintained laboratory instruments to warranty their accuracy and utilization such as HPLC, GC, FTIR, Vis-UV, ICP, dissolution apparatus, auto-titrator, etc.• Documented comprehensive, accurate and timely experimental observations.• Provided techniques and problem-solving solutions that support troubleshooting complex instrumentation and method problems

• Analyzed different dosage form samples in full testing, including identification, dissolution, water determination, assay, content uniformity, purity, related substance, residual solvent, wet chemistry and physical testing.• Interprets and documents all test results, calculation, and observation.• Interact with R&D group on method development and validation.• Cooperated proactively with team members on multiple projects and met tight deadlines.