AVNISH THAKUR

Responsible for area production planning and execution, shift management, and active involvement in QMS activities, including leading change control implementations, contributing to CAPA investigations, and managing OOAC processes.

Responsible for equipment qualification process (URS, DQ, IQ, OQ, PQ) for the Line IV brownfield project, overseeing a team to deliver compliant results.

Responsible for enhancing employee knowledge and skills by conducting regular staff training sessions.

Ensured smooth operation of aseptic manufacturing processes, coordinating shift activities from dispensing to external vial washing, optimizing production while maintaining sterility.

Ensure timely deliveries, optimize productivity, manage manpower, and maximize yields.

Monitoring documentation and system implementation to ensure adherence to standards.

Monitoring of process validation of existing products.

Planned, coordinated, and managed production activities and resources, ensuring strict compliance with SOPs, Batch Records, and Quality Systems.

Streamlined operations for increased efficiency by identifying bottlenecks in batch manufacturing processes and implementing targeted solutions.

Cultivated a culture of continuous improvement by promoting open communication channels for feedback from all levels within the organization.

Streamlined operational processes to improve efficiency and reduce costs.

Supervised Aseptic sterile Injectable manufacturing line with 12 team members, overseeing the batch activities and qualification activities.

Successfully resolved team conflicts and built trust with senior management.

Resolved two critical problems in aseptic area, saving one hour per batch.

Skills: GMP · Team Management · Aseptic Manufacturing · Sterility Assurance · Teamwork · Sterilization · Team Building · Time Management · Continuous Improvement · Validation · Problem Solving

Enhanced production by 20% daily through a strategic shift redesign that optimized line utilization during lunch hours.

Fostered a culture of sharing best practices, challenges, and concerns, driving innovation and district-wide improvement.

Equipped 4 technicians with the skills and knowledge to take on officer roles.

Identified and recognize "Innovation champions" for smoother process adoption.

Successfully interacted with auditors ( EMA- Health Canada) achieving zero observations.

Improved communication between junior and senior levels in a 24/7 operation.

Planned, coordinated, and managed production activities and resources, ensuring strict compliance with SOPs, Batch Records, and Quality Systems

Aseptic processing expert with experience in autoclave, vial washing, and tunnel operations.

Packaging operations.

Maintained accurate documentation of production data, facilitating informed decision-making by supervisors.

Oversaw all aspects of dry powder filling, from process setup to final product packaging.

• Graduation with Distinction, 75% Aggregate.
• Publish Research Article "Stabilization of calcitriol in tablet dosage form." in International journal of institutional pharmacy and life sciences accepted 08/08/2012
• Six months training in F&D Cadilla pharma Dholka, Completed in January 2012.

• Final Grade: 80 %