Working as Assistant General Manager, Head- Quality Assurance, MR & FSTL in Suven Pharmaceuticals Limited at Suryapet Facility , Suryapet District, Telangana State since March 2005. Expertise in QMS, cGMP trainings and Data Integrity and Audit Trails. Supplies Drug Intermediates for Global Pharma Industry to various Customers like Bayer healthcare, Sanofi, GSK, Pfizer,BMS, Lundbeck, Wave length, Mitsui,Otsuka, Du Pont etc. Performed 250+ vendor and internal audits to qualify vendors on regular basis across the country

 Responsible for overall quality systems throughout the facility. Effective implementation of Quality Systems by cGMP & ISO standards to meet the customer, certification and regulatory requirements Conducting Annual Product Quality Review for monitoring the product consistency Carryout internal audits as per schedule across the facilities and conduct M R M periodically Approval of Master Batch Production Records (BPRs) and filled in BPRs. Approval of SOP, STP and other relevant documents Batch release & distribution. Approval or rejection of reprocess / rework of materials Scale up and technology transfer data from R &D for new product development Coordinate Risk assessments and change control management and its effectiveness. Handling of the deviations and root cause identification. Finding root cause of the OOS results and final decision-making. Coordination with Corporate Quality Operations(CQO) in implementation of SOPs Qualifying the vendors of raw materials and intermediates. Product recall and handling of the market complaints. Customer audit responses, questionnaires, quality agreements & CMC Equipment/Utilities/Instruments Qualification for across the facility Master Validation Plan - Validation of Protocols & Control plans. Validation life cycle Excellent communication and Facilitation skills Mentoring, coaching, or in classroom training, etc.  Administratively reporting to Vice President-Unit Head, Functionally reporting to V P- CQO  Earlier served as Manager - Quality Control at same site. Quality Compliance Product Quality Review & process improvement initiatives along with QC, R&D, Production Departments. Approving all the Standard Operating Procedures (SOPs), protocols and reports  Resolving of quality related customer complaints, returnsl to their queries through investigations Qualification & Validation, Stability Protocols & Reports of various products and its approval.

Method Development, Analytical Method Validations,Stability Studies,Out of Specifications for all Raw materials and Finished Products.Conduct in-house training and qualification of Analysts.Release of materials, Document review and Certificate of Analysis by GMP Pro.

* Analytical Method Validation, Stability Studies as per ICH guidelines.* Planning, allotment and distribution of work to Juniors.* Calibration and Operation of instruments like HPLC, GC, FTIR, UV and Polarimeter etc

Statistical sampling and testing of raw materials, interrmediates , and finished products and documentation the same as per GLPDosage forms HandledSolid - Tablets, Capsules, Liquid - Syrups, Ointments, Creams etc as per IP/BP/USP/EP norms.Internal, Customer, and Regulatory audits including Johnson & Johnson, Procter & Gamble, Marico, Wardex, Himalaya, Cavin Kare etc.

Trainee Chemist.Sampling and Analysis of Raw materials,Inprocess samples and finished products and documentation .Dosage forms HandledSolid - Tablets, CapsulesLiquid - Syrups