Mahesh Dhote
Officer at Viatris l Product compliance Quality Assurance l Regulatory Compliance and Praparation Documention for Drug Approval l Risk management l Standard operating procedures l investigation & CAPA, Root Cost
- Role
- Officer in Quality Compliance at Viatris
- Location
- Indore, IN
- LinkedIn followers
- 500 followers
About Mahesh Dhote
DRA officer in Mylan Pharmaceutical. i have gained experience in ensuring the quality…
Experience
Officer in Quality Compliance
Jan 2023 — Present · Indore, IN
Quality control analyst work in accordance with approval method sop\'s and cGMP/GLP, while performing tests in various techniques like UV,IR, KF titration, particle sizing, HPLC. GC,etc.Developed and implemented quality management system and procedures for pharmaceutical product and services participate in continuous improvement project and provide technical support to other department as needed.helps in data management, project management and Adit related queries.Executed various transaction in sap,LIMS CARA D2 Documentation and track wisesupport in establishing and controlling of Raw Material supplier qualification program.Analytical method development and validation studies and assist in technology transfer activities.Attention to detail and accuracy in documentations and data interpretation.participate in internal and External audits, and assist in preparing responses to audit observations. Conducted risk assessment and investigation to identify potential quality issue and implemented corrective action applies cGMP concepts in association with department specific responsibilities Ensured compliance with all applicable regulations and guideline, including FDA, EMA and ISO,CDSCO.
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