SANDEEP VERMA

Looking for a self-motivated work environment and challenging position where I can add value to the Organization through utilizing my experience, knowledge of operations and education in modern business arena.

Dynamic professional with 17+ years of experience in Quality Assurance including Regulatory Affairs, presently associated with Indovax Private Limited (Incorporated in 1986, Indovax Private Limited is a leading manufacturer of biologics in India. The company is in the forefront of development, manufacture and marketing of poultry vaccines).

• Recognization for Good Performance by Management at Indovax.
• Promoted as Executive at Glenmark for Good Performance.
• Awarded as Best Player in Cricket at School.

• Teaching & Learning
• Painting and Art & Craft
• Educational Research & Innovation

• Hindi
• English

QMS-Review of customer complaints, change controls, deviations, Incidents., Expertise in investigation through different investigative tools like Fish Bone, FTA, 5why etc., Preparation, review and monitoring of various validation activities such as Equipment qualification, Process validation, cleaning validation and Facility qualification as per the approved protocol and Validation Master plan., To prepare & review Risk assessment of the Equipment/Process/Facility using tools such as FMEA as part of Quality Risk Management., Preparation of master documents such as Site Master File & Validation Master Plan., Quality Risk Management Plan (QRMP)- Evaluates potential product quality compliance with respect to cross contamination in accordance with the Code of Federal Regulations 21 CFR 211.42., Have a good understanding about different formulations manufacturing., Knowledge of the SAP and TRACKWISE software with respect to QMS application., Effective CAPA tracking with evaluation of the same., Effective review and Monitoring of Validation activities like Cleaning Validation, Process Validation., Hand holding on Qualification of Equipment and Facility., Preparation of dossiers for Indian and International market., Registration of products for Indian and International market., Preparation of CTD and PSF documents for submission., Timely compile for license renewals, updates and registrations., Maintain regulatory files/database and chronologies in good order., Establish and maintain system for tracking changes in documents submitted to agencies or partners., Assured that existing and new products complied with all laws., Monitored the development and assesses the impact of new and proposed changes in laws., Communicated new requirements and changes within the organization., Exposure of Quality Audits: USFDA, MHRA, WHO-GENEVA, MCC, EU-GMP, TMDA, ANVISA, NAFDAC, PPB, EDA etc., Preparation of audit compliance reports and CAPA management., Self-inspections., Ensuring that non-conformances are duly complied with the regulatory requirements and norms.

• English
• Hindi

• Playing (i.e., Cricket, Table Tennis, Football, Badminton)
• Health and fitness (i.e., Yoga, Going to the gym, Cycling)

• Ability to learn new skill very fast, quick learner and good observer.
• Self-confident, calm, composed and tolerant of ambiguity.
• Believes in knowledge sharing and team management.
• Have flair for continuous improvement and self-development.
• Excellent motivator, innovator and Inspiring Leader who leads from the front.

• Father's Name: Sh. Inder Verma
• Mother's Name: Smt. Neelam Verma
• Date of Birth: 07/03/83
• Gender: Male
• Nationality: Indian
• Marital Status: Married

I hereby solemnly declare that all above said information about me is fully correct to the best of my knowledge.