Thippeswamy V Email and Phone Number

• Senior Management Executive with multi-function experience over 23 years in Pharmaceutical Industry.• Heading a team of Quality Professionals for Quality Control, Quality Assurance functions and ensure adherence of all Quality objectives designed & Implemented through Quality Policy, Quality Management Systems & Quality Assurance Procedures.• Successful in setting up of facilities like Laboratory, Warehouse, Manufacturing, Utilities etc. with complete Qualification and validation.• Design, implementation, regularization & review of Quality Management Systems and procedures and following-up of practices in line with Regulatory requirements.• Adequate experience in the areas of QA, QC, Technology Transfer & Manufacturing.• Product Exposures – Solid dosage forms, Lozenges, ODTs & Liquid Orals, Parenteral & Others.• Successful Management of Major Regulatory Inspections & customer Audits through follow-ups & meeting pre & post Compliance requirements.• Auditing Capabilities and audited API, PPM, CTL facilities across India & abroad which are Accredited by various Regulatory Agencies.• Achieved efficiency in Analysts, Instrument Performance & trouble shooting.• Effective Stability study management and timely generation of reports.• Successful Implementation of Access & Privilege Controls Software to ensure no data integrity issues prevail in the laboratory and Computer system validation.• Successful Completion of Computer System Validation and related Risk Assessment & Mitigation for Laboratory and Manufacturing equipment.• Commitment for Quality is Ultimate to deliver product meeting Quality, Strength, Purity, Safety & Efficacy criteria.

 Heading teams of Quality Professionals like Analytical Services, Quality Assurance & Formulations functions to monitor & ensure adherence of Quality Policy, Quality Management Systems & Quality Assurance activity. Successful Creation, Designing, Organizing, Execution of New Quality Dept. through Quality Management Systems & Documentation.  Successful Management of Central, Local & Customer Inspections through Audit Preparations & meeting post Compliance requirements. Effective Maintenance of Facility, Systems & Practices to meet Regulatory requirements through Quality Policies, Quality Management Systems, SMF, VMP & SOPs. Set Strategy planning to enhance the business. Implement, Control & Review complete documentation systems & practices in adherence to regulatory agencies. Control & Review validation and qualification activities with respect to equipment, system, process & product. Control & Review of system-based controls like Change Control, Deviation, OOS, OOT & CAPA. Ensuring Technical Agreements with all Vendors & periodic review in line with these requirements. Introduction of new technologies & requirements in the organization to meet the cGMP requirements. Dealing with customers for all technical reviews/ discussions, Quality related updates through desired inputs & support to meet their quality management objectives. Review & Approval of IQ, OQ, PQ & Calibration of Instruments & Equipment. Surprise auditing of Analytical Department to ensure continuous compliance. Review & Approval of the Raw material, In-process, Finished products & Stability reports to ensure compliance against regulatory requirements. Review & Approval of the Specification, Standard Test Procedures & Standard operating procedures, Quality assurance procedures & Stability data. Conducting frequent quality management review program to evaluate the quality & business aspects.

 Handling of Deviations, OOS, OOT, Change controls etc.  Review of above QMS documents with respect to Investigation, Impact analysis, CAPA & Its effectiveness. Periodic review of training related documents. Responsible to implement cGLP, cGMP & Quality Assurance Procedures effectively in accordance with company’s Quality management activities. Review of IQ, OQ, PQ & Calibration of Analytical Instruments & Equipment’s. Responsible for frequent Auditing of Analytical Department as per self-inspection plan and also to ensure compliance against previous audit observations. Active participation in Regulatory Audits like WHO, MHRA & ROW. Responsible for Auditing of Vendor as per guidelines of In-house & other regulatory requirements. Review of submission documents & Coordination with Regulatory Affairs Department to smoothen the submission process. Responsible for review of the Raw material, In-process, Finished products &stability reports to ensure compliance against regulatory requirements. Responsible for review the Specification, Standard Test Procedures & Standard operating procedures, Quality assurance procedures & Stability data.

• Planning and execution of Raw-material, In-process, Finished products & Stability sample analysis for Related Substances, Assay, Dissolution, Dissolution profile& all other chemical analysis as per Pharmacopeia/Approved methods.• Responsible for review & ensure the compliance for the Raw-material, In-process, Finished products & stability sample reports and subsequent release.• Responsible for preparation & review the Specifications, Standard Test Procedures & Standard operating procedures • Calibration & Review of Analytical Instruments & Equipment’s as per the planner.• Preparation and review of all Analytical Method Development, Validation/verification and Method transfer reports.• Preparation and review of Stability Protocols & Stability data compilation and interpretation.• Final review and correction of all Analytical documents for regulatory submissions.• Responsible for the overall activities and compliance in the Quality control division.• Actively involved in internal audits & Regulatory audits like USFDA, TGA, MHRA, WHO etc.Strides Arcolab Limited Executive - Analytical services July 2005 – June 2007  Analysis of Raw materials, Finished Products & Stability study samples Preparation and Review of Analytical method validation Protocols and Reports & Stability analysis reports. Analytical Method Development, Method Validations and Stability analysis of Drug products as per ICH guidelines. Analytical Method transfer to the manufacturing sites. Periodic Calibration of Instruments. Revision of SOP’s & STP’s as part of continuous improvement and regulatory requirement

 Analysis of active in Raw-materials, Intermediate samples & extracts and finished products. Analysis of Solvents, moisture and non-volatiles to online fine-tune the solvent parameters during process. Analysis of Raw water, processed water & effluent water. Routine maintenance of log and production data. Handling of control samples (Periodic review & analysis). Process development activities for the up-gradation of Product & Formulations.