SUDHIR ARORA

Career Objective : To be associated with an organization where I can utilize and Implement my Aseptic Manufacturing, Commissioning, Qualification, Validation, cycle development knowledge & skills as per Regulatory Standards which I have developed during my entire assignments from last 12 years in Injectable production and work for the betterment of the organization in the best possible way with Compliance and Productivity. To seek and maintain full-time position that offers professional challenges utilizing interpersonal skills, excellent time management and problem-solving skills.

• Monitoring and Participating in Batch Compounding , Aseptic Filling, Media Fill Activities and provide the support to manufacturing team at different stages of Production activities.
• Execution, Review and compilation of Batch Manufacturing Records.
• Preparation and Review of Equipment Qualifications and validation Documents.
• Placebo, Scale up , Exhibit and Commercial Batches BMR Preparation, Revisions and their Execution.
• Handling of QMS Documents like change control, Incidents, Audit compliance and closure of same within the timeline by coordinate with QA and other supporting department.
• Planning Daily and Weekly Batch production activities and their schedule.
• Planning and Allocation of shift related activities of Manufacturing Team as per batch production plan.
• Review and compilation of Production Schedule activities like NVPC Trends, Filter Integrity Reports and Equipment Alarms Trends.
• Actively Participating in Equipment Re-Qualification of HPHV Steam Sterilizer, Vial Washing. Sterilizing and Depyrogenation Tunnel.
• Oversight on all manufacturing operation activities in all shifts and weekend.
• Responsible for time to time execution of Training of employees by Coordinating with training department.
• Regularly review of manufacturing operation, procedures, batch records and training documents for Continuous Improvement.
• Creation of Purchase requisitions and Procurement of New and Existing consumable required in Facility time to time for smooth running of Production activities.

• Preparation of Equipment Qualification Documents like User Requirements Specification, Design Specification, Risk Assessments, IQ and OQ.
• Execution of Qualification activity like DQ, IQ, OQ and PQ related to facility equipment Like Dynamic pass box, LAF, Steam Sterilizer, Vial Washing Machine, Depyrogenation Tunnel, Lyophilizer and Filter Integrity Tester.
• Handling of QMS Documents like change control and Deviation in QAMS Caliber, QEdge and Trackwise system and closure of same within the timeline by coordinate with QA and other related department.
• Responsible for preparation of sop’s related to the shop floor, equipments handling and Operation and actively involved for their effectiveness by completion of training through QEdge System
• Preparation of Master Production Control Records.
• Implementation of 21 CFR Part 210,211 in Facility Equipments.
• Exposure to handling of Complex Molecules like Insulin Injection and Hormonal Products like Medroxy Progesterone.
• Media fill Planning and Successful execution of Media Fill Runs for facility Qualification.
• Creation of Purchase requisitions of New and Existing consumable required in Project Facility and maintains the overall department consumables in SAP system
• Supervising the shift activities related to clean area washing, Tunnel, autoclave and Component Preparation.
• Responsible for time to time execution of Training of workman by Coordinating with training department in QEdge System.
• Maintain the daily production report and submitted to department head.
• Complete SFG, FG transaction, BOM and recipe Preparation of product in SAP System.
• Control man & material movement on shop floor.

• USFDA
• MHRA
• WHO
• PPB KENYA
• NDA UGANDA

• Steam Sterilizer makes Fedegari, Indo German & Machin Fabrik.
• Vial and Cartridge Washing Machine make Bosch, Groninger, Trucking, Tofflon and Klenzaids.
• Vial Depyrogenation Tunnel Make Bosch, Groninger, Trucking, Tofflon and Klenzaids.
• Manufacturing and Holding Vessels make Adam, Bright Pharma, Praj and Biosphere.
• Vial Filling Machine make Trucking and Tofflon.
• Lyophilizer Make Tofflon.
• Integrity testing machine make Sartocheck 4 Plus & Palltronic Flowstar 4
• CIP and SIP System (Adam and Bright Pharma).
• Blister and carton Packing Machine make Pam Pac.

Name: Sudhir Arora

Father’s Name: Sh.Ram Lal Arora

Date of Birth: 11th May 1988

Sex: Male

Nationality: INDIAN

Marital Status: Married

Blood Group : O+

Address: H.No. 131/11, Ekta Colony, Bangran Road, Paonta Sahib (H.P), Pin- 173025

Mobility: Willing to Relocate anywhere in India

I here by declare that all the information provided here are correct to the best of my knowledge and belief.

Place: Paonta Sahib