Handling the Quality Management System through initiation and management of change controls, non conformances and performing detailed investigations for healthcare products.Performing Product release in system after Client QA provide the approval.Update and maintain SOPs, Client Specific SOPs, Work Instruction, Client specific External Documents.Review Certification of Destruction, Sanitation records, Pest Control records of monthly inspections. Conducting regular inspections of the facility and recordkeeping, including summarization and reporting of findings.Identifying and implementing effective CAPAs and performing Root Cause Analysis for NCs associated to healthcare products and ensuring their effectiveness by periodic monitoring.Facilitate GMP and GDP training sessions for warehouse associates and provide guidance whenever needed Providing feedback and assistance to Customer/Client QA related questions and concerns.

Provide Quality Assurance & compliance support to Production, Quality Control laboratory, Materials Management and other GMP functional areas to ensure compliance to cGMPs, SOPs, and applicable policies.Author and review change controls for completeness, log, and route for approvals; execute approved change controls to prepare master documents, obtain approvals, and issue controlled documents. Maintain change history logs.Archive and maintain GMP Master Documents such as Test Specification Forms, Test Methods and SOPs.Archive and maintain GMP Documentation and Records including GMP and SOP Training rosters, Calibration certificates, Pest Control Inspection Reports, and controlled log books.~ Conduct environmental monitoring of production area as per Standard Operating Procedures.Maintain adequate inventory of supplies for environmental and water monitoring.Author Non-Conformance Reports, as assigned; conduct investigation, and assign/performCAPA, as required.Coordinate equipment and facility calibrations and maintenance activities managed by Quality Assurance; liaise with vendors and contractors to obtain quotations and coordinate work, as applicable.Perform A review of calibration certificates and pest control inspection reports.Prepare/review IQ, OQ, & PQ protocols and reports for equipment, utilities, and automation systems, as directed. Maintain life-cycle documentation such as URS, FRS, FAT, and SAT, as applicable.Coordinate equipment and facility qualification projects to meet target timelines; liaise with internal stakeholders to plan and schedule qualification activities.Perform sampling coordination for Process and Cleaning validations, as assigned.Perform release of incoming materials, as assigned.Write/revise department SOPs as required to comply with cMP and other applicable standards.~ Assist in internal audits of GMP functional areas, as assigned.Assist in preparation for regulatory inspections and customer audits.

Providing quality guidance and recommendations for MES Recipe Authoring team; verifying the MBR Master data for a range of parametersReview MES-MBR records to ensure equivalency with paper-based records, review MES bills, processing steps, critical process parameters and controls.Review Change control content, Certificates of Compliance, Certificate of Analysis and rational statements to ensure compliance with regulatory requirementsEnsures business requirements (at lowest level of detail) will be met by the MESActs as a change agent, to identify and drive the business changes. Reviews and provides feedback to Change Management team on communication efforts, change plans, job role definitions, training materials.Uses knowledge in functional area to understand and improve individual, work group, and/or organizational results. Leverages industry best practices applicable to the work functionIdentifies improvement opportunities, generates ideas, and implements solutions. Fosters a continuous improvement mindset to streamline and harmonize functional processes and systems.Sets goals, prioritizes tasks, and monitors progress toward goals.Responds quickly and effectively to rapid, frequent, and unforeseen change. Approaches challenges with effective problem-solving abilities.

Identified the causes which reduce the operating efficiency by using DMAIC toolsand Lean Management.Worked successfully with diverse group of coworkers to accomplish goals andaddress issues related to our products and services.Processed all material movement and planning transactions using SAPCollected product samples at precise times using correct methods to monitor andanalyze chemical processes.

• Plan, conduct, and supervise test and inspection of materials and products to ensure quality is maintained with collaboration with sanitation department to maintain contamination control• Involvement in steps of food manufacturing procedure for food safety, processing and storage in terms of managing environmental factors to control and maintain quality and life cycle of frozen food.• Assist Supervisors and Team leads with the production planning activities• Take record of internal audits and other quality assurance activities• Perform Final review of all finished product batches• Collect and compile statistical quality data• Draft assurance policies and procedures as per HACCP protocols• Interpret and implement quality assurance standards as per FDA and Health Canada policies.• Devise sampling procedures and directions for recording and reporting quality data• Entails providing training to production staff on compliance with regulations, policies, and standard operating procedures following SOPs and MSDS protocols.• Occasionally conducting training to employees for guiding WHIMS and health and safety measurements.• Good Laboratory Practices implementation for lab setup and maintainable• Detailed understanding of MES (manufacturing execution system)

• Worked in a team to prepare the raw materials and finished products Analytical Certificate• Conducted routine wet-chemistry tests for chemical and pharmaceutical product analysis• Utilized HPLC, Karl-Fischer titration, IR andUV instruments to perform assay tests• Performed tests on USP dosage units to determine hardness, friability, viscosity, uniformity of dosage units and limit tests to identify the heavy metals and Inorganic impurities content• Performed dissolution tests to prepare dissolution profile of US for immediate delayed release tablets in single multiple points media and pooling technique• Prepared and reviewed SOPs/methods/ protocols, as well as change control requests as per established SOP/protocol requirements• Performed and documented analysis of raw material, in-process and finished products according to USP and in-house methods/ protocols

• Performed identification tests, LOD, specific gravity, bulk and tapped density, friability, hardness, limit tests• Prepared dissolution media and conducted dissolution using dissolution apparatus 1 and 2 • Developed skills in testing using HPLC, TLC, UV/VIS, FT-IR, Karl Fisher titration, etc• Calibrated analytical balances, pH meters• Performed HPLC method validation• Performed and documented all lab works• According to guidelines of GMP, gained knowledge of FDA and ICH regulations• Developed knowledge on pharmaceutical auditing, technical writing and regulatory affairs