Accomplishing quality assurance human resource objectives by recruiting, selecting, orienting, training, assigning, scheduling, coaching, counseling, and disciplining employees; communicating job expectations; planning, monitoring, appraising, and reviewing job contributions; planning and reviewing compensation actions; enforcing policies and procedures.Achieving quality assurance operational objectives by contributing information and analysis to strategic plans and reviews; preparing and completing action plans; implementing production, productivity, quality, and customer-service standards; identifying and resolving problems; completing audits; determining system improvements; implementing change.Meeting quality assurance financial objectives by estimating requirements; preparing an annual budget; scheduling expenditures; analyzing variances; initiating corrective actions.Developing quality assurance plans by conducting hazard analyses; identifying critical control points and preventive measures; establishing critical limits, monitoring procedures, corrective actions, and verification procedures; monitoring inventories.Validating quality processes by establishing product specifications and quality attributes; measuring production; documenting evidence; determining operational and performance qualification; writing and updating quality assurance procedures.Preparing quality documentation and reports by collecting, analyzing and summarizing information and trends including failed processes, stability studies, recalls, corrective actions, and re-validations.Responsible for review and approval of investigations, CAPA's, change controls and deviations.Responsible for maintaining, updating and tracking of quality metrics for weekly trend review and compliance meetings.

Leading the GMP compliance efforts for pharmaceutical production process related to solids/ liquid/ ointments/ creams/ gel/ powder for solution/ suspension oral dosage forms.Monitoring and auditing manufacturing for cGMP compliance and serving as a key resource to production and laboratory activities regarding quality and compliance issues.Supervising the manufacturing floor activities and all GMP documentation with seven direct reports.Resourcefully participated in handling market customer complaints (Quality complaints as well as Adverse drug event complaints) by investigating the complaints and to rectify by identifying the root cause for the same.Enthusiastically assisted in the training of new and current employees in the manufacturing, formulation development department, and quality departments regarding cGMP and other quality related issues.Responsible for maintaining and improving product quality by completing internal product, company, system, compliance and surveillance audits, investigating customer complaints; collaborating with FR&D and engineering departments to develop new product and engineering designs and manufacturing and training methods. Review of equipment qualification documents, packaging / manufacturing batch records, process performance qualification protocols, cleaning validation / verification protocols, process study protocols, investigational product sampling protocols, blinding study protocols, stability protocols, reprocessing protocols, change controls, planned deviations and unplanned investigation reports.Responsible for performing vendor audits as well as audits at the CMO sites.

Validation - Preparation of Process Validation Protocols for ANDA submission batches, validation and commercial batches. Coordinate activities with R&D and Operations departments for procurement of raw materials, material releases & documentation of project's progress. Performing Environmental Monitoring studies, which includes Microbiological Air Sampling and Equipment Rinse and Swab Sampling.Preparation of Cleaning Verification & Validation Protocols for new products analyzing the product contact areas and the designing cleaning methods to be used for various equipments.Accomplishment - Successfully executed Validation program for more than 14 commercial and 24 ANDA filings.

Multitasking Position reporting directly to Sr. Director, Quality Management. QA Coordination - Review process change requests, planned deviations and interface with R&D and Manufacturing departments regarding change requests & customer complaints, Prepare Annual Product Reviews, Review and revision of Quality Department SOP's, Batch Record Issuance & review, Label control. Assisted in the training of new and current employees in the manufacturing, Formulation development department, and quality departments regarding cGMP and other quality related issues.Stability Co-ordination -Responsibilities included Daily oversight and maintenance of stability program in accordance with ICH and FDA stability guidelines and requirements, Generating stability protocols, interpreting results, and writing interim and final stability reports. Monitoring, maintaining and qualifying stability environmental chambers. Experience with LIMS for Stability Coordination with the Laboratory.Accomplishment - Implemented systematic Stability Scheduling and enhanced the stability sample program.Accomplishment - Streamlined the Change Control System and created new SOP's for QA. Prepared investigation reports for process deviations, failures, complaints, and CAPA's.Working under strict cGMP environment, Responsibilities include supervision of line clearances for Production and Packaging line, Perform raw material sampling, in process checks, finished product sampling from Blends, compression, Coating, as well as liquid manufacturing. Overall Monitoring of Water System

Performed water content of the finished products using the Karl fischer titration.Performed HPLC, UV spectroscopy, and titrimetry in accordance with the SOPs