Sarath Babu Chintha

Educational Qualification: M. Sc. Biotechnology from Bangalore University, Bengaluru, Karnataka. Expert in Data entry and data analysis work. Experienced in Pharmaceutical industry: Review of Qualification and Validation activities (CQV) and other QMS integrated functions. Preparation of Standard operating procedures for Quality Assurance department. Monitoring of the IQ and OQ activities and handling of the deviations if any. Conducting Quality Risk Management exercise’s for facility layouts, utilities and equipment. Review of validation life cycle of equipment and utilities. Provide training for team members on Qualification and validation activities. Review of Validation Master Plan. Review of Equipment / Utility / Process validation protocols. Preparation and review of SOPs related to the validation activities. Track the CQV (Commissioning, Qualification and Validation) schedule’s and escalate the impact of the validation activities. Initiation, tracking and closure of change controls, Deviations, CAPAs and internal audit observations pertaining to qualifications/ validations. Monitoring of manufacturing QA activities. Monitoring of training requirements at site for the employees. Preparation of Validation Master Plan. Preparation of monthly qualification / Validation schedules and tracking for execution. IQ, OQ, PQ & PRQ protocols preparation and execution of equipment / utility / facility qualifications & validations for, 1. Glass Vial line 2. Ampoules line 3. Pre Filled syringes line 4. Ophthalmic filling line 5. Blow fill & seal line 6. Form fill & seal line Initiation, tracking and closure of change controls, Deviations, CAPAs and internal audit observations pertaining to qualifications/ validations through online quality management system. Preparation and compilation of Aseptic Media fill validation protocols. Preparation and compilation of process validation protocols. In-process Quality assurance activities (Manufacturing Quality Assurance): Area and equipment line clearance and monitoring of IPQA activities in Dispensing Area/Manufacturing Area/Filtration/Filling/Visual/Labelling/Packing areas. Verification of Current Good Manufacturing Practices at shop floor. Preparation of annual product review and compilation. To check and review of BMR at each stage and ensure records are filled online and as per Good Documentation Practices. Collection of bulk sample, sterility sample, finished sample and reference samples. To carry out Pre-dispatch inspection of a Finished Product. Handling of Market complaints and Batch failure investigation. Other Details: Language Skills Speak, write and Read fluently in Telugu, Hindi & English. Speak – Kannada. Computer Skills: MS Office Strengths: Flexible for taking up new challenges Self-Confident Enthusiastic in learning new things Applicability Permanent Address: C. Sarath babu S/O C.V. Obulesu H.No.#27-8-746 Beside Sivabalayogi Temple Sri Sivabalayogi Nagar Muddireddypalli (Po) – 515202 Hindupur (M), Ananthapur (Dt), Andhra Pradesh, India