Aswini Kumar Mahapatra

M. Pharm with 9.3 years of rich and diverse experience in Production department, the experience ranges from Coating, Capsule Filling , Documentation, and regulatory Compliance to overall quality improvements. Comprehensive Problem Solving abilities, excellent verbal and written communication skills, willingness to learn, team facilitator. Efficient Role played in Regulatory audits like USFDA, MHRA, TGA.

• Responsible for Production operations and monitoring of scale up, exhibit and commercial batches as per schedule.
• Implementation of Current Good Manufacturing Practices in production area to meet the Regulatory requirements.
• Handling of software like CAPA Trackwise, DCM, LMS.
• Handling and Calibration of in-process equipment.
• Optimum utilization of resources.
• Ensuring that all the SOP’s related to production areas are implemented as per procedure.
• Ensuring engineering activities such as preventive maintenance, routine and breakdown maintenance, calibration, Equipment and Area validation are carried out as per schedule.
• Reviewing and executing BMR with respect to all relevant entries.

• USFDA (United States)
• MHRA (UK)
• ANVISA (Brazil)
• Internal Audits

• Participated in cGMP training program held by Sun Pharma Ltd.
• Training program on 'Supervisory skills Development' by Sun Pharma Ltd.
• Training on Good documentation practices.

• Hindi
• English
• Odia

• Father's Name: Sh. Purna Chandra Mahapatra
• Date of Birth: 10/05/94
• Gender: Male
• Nationality: Indian
• Marital Status: married