SATISH MIRIYALA

Dedicated Pharmaceutical professional with a history of meeting company goals utilizing consistent and organized practices. Skilled in working under pressure and adapting to new situations and challenges to best enhance the organizational brand.

• Review of Standard Operating Procedures and Stability Protocols
• Review of In-process, Finished and Stability Documents analytical raw data
• Review of Analytical Method Validations, Process Validations and Cleaning Validations analytical raw data
• Participate in internal audits in Quality Control department
• Handling and Review of OOS, OOT and Incidents
• Handling of Document Change Controls
• Handling and Review of customer complaints
• Handling of regulatory queries
• Quality Control (GLP):
• Preparation of Method Validation protocols, worksheets and reports
• Preparation of RM, PM and FP Specifications, Standard test procedures and Analytical test data sheets of finished products, in process, packing materials and raw materials
• Preparation of Dispatch COA’S
• Preparation and implementation of SOP’S
• Maintenance of reference standards and working standards
• Maintenance of calibrations of all the instruments of Quality Control
• Performed Method verification and Method validations
• Ensure the functions of instruments section as per the requirement of current regulatory guidelines
• Regulatory Audits Exposed
• Pro-actively involved in the regulatory facility audits i.e USFDA, EU GMP, KFDA, WHO GMP
• Actively involved in Customer audits, provided technical support to QA during audits
• Instruments Handled
• SHIMADZU HPLC with LC software
• SHIMADZU HPLC with Lab Solutions software
• WATERS HPLC and AGILENT HPLC with EMPOWER software
• ELECTROLAB DISSOLUTION apparatus
• SHIMADZU UV spectrophotometer
• PERKIN ELMER IR Spectrophotometer
• CONFERENCES, WORKSHOPS, WEBINARS AND SEMINARS
• Actively participated in the GMP and GLP training workshops in Lee Pharma
• Participated in a workshop conducted by Shimadzu on HPLC systems in Visakhapatnam.

• CO-CURRICULAR ACHIEVEMENTS
• Spearheaded & successfully conducted branch fests during graduation & Post graduation.
• Active Volunteer in NSS Program. INTERESTS & HOBBIES
• Watching movies & Listening music
• Travelling
• Farming