Vinay's Resume
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Vinay Kumar is seeking a challenging career in a progressive organization where he can utilize his 5+ years of experience in quality assurance for oral solid dosage forms for regulated markets. He has experience reviewing quality incidents and conducting investigations, handling product quality reviews, ensuring GMP compliance, and authoring investigation reports. Vinay Kumar held positions at Dr. Reddy's Laboratories, Mylan Laboratories, and Arvind Remedies where he was responsible for tasks like batch record reviews, audit preparations, training programs, and automation of production processes. He has a Master's degree in Pharmacy from Vel's University and a Bachelor's degree from HITS College of Pharmacy.
Vinay's Resume
- 1. YADA VINAY KUMAR Flat # G3, Satyaprasad Enclave, Bachupally, MOBILE: + 91 9542711313 Qutbullapur, Hyderabad, Telangana, INDIA. MAIL:yadavinaykumar@drreddys.com vinaykumaraug28@gmail.com OBJECTIVE: Seeking a challenging career in a progressive organization, which utilizes my skills and capabilities and assists me in building up my career and the organization. PROFESSIONAL SUMMARY: 5+ year experience in Quality Assurance of oral solid Dosage forms for regulated markets (US, EU, TGA,Emerging markets) Review of Critical and Major Quality Impacting Incidents at Site Level(Site Investigation Team) Handling of Product Health Management-Investigation of OOS and OOTs. Exposure with regulatory audits (USFDA, MHRA, ANVISA, TGA, MCC, MOH .) Monitoring and ensuring of GMP in all unit operations (IPQA). Preparation and review of APQR Audits and compliance. Preparation and review of investigation reports associated with incidents/events. GAP Analysis Recipe handling. (Automation of all critical process by reducing manual intervention) PROFESSIONAL POSITIONS: Assistant Manager at Dr. Reddy' s Laboratories (FTO Unit 3), Bachupally, Hyderabad. (2 years' experience) Handling of Automation of all critical production activities. Recipe management. Preparation and review of investigation reports for Quality Impacting incidents and OOS/OOT results Proposing CAPA and verification of CAPA effectiveness. Preparation and review of APQR.
- 2. Expertise in all kinds of Blend sampling techniques.(CU Normal, CU Manual Compaction,CU vertical) Driving of Change control process for automation of the existing manual operations. Officer at Mylan Labotaories Ltd., Nasik ( 06 months experience) Monitoring and ensuring of all IPQA activities. Batch Record review . Coordinating with validation team for execution of validation batches. Review of documents for calibration, log books. Executive at Arvind Remedies , Chennai (2 years experience) APQR preparation and review. Review of Batch manufacturing records. Performing all Inprocess Activities. Ensuring GMP on shopfloor. To monitor and conduct the training activities on c-GMP, and on new procedures as well as revised procedures, etc. EDUCATIONAL CREDENTIALS Masters in Pharmacy, Pharmaceutics 2011, First Class with Distinction, Vel's University, Chennai. Bachelors in Pharmacy, 2009, First Division, HITS College of Pharmacy, Hyderabad. TECHNICAL SKILLS Well versed with MS Office and SAP (Production Module) KEY PERSONAL ATTRIBUTES Highly energetic with good learning ability and execution skills Proactive approach towards understanding work & execution as per plan Good communication skills both written and verbal Well versed with MS office.
- 3. PERSONAL DETAILS: Fathers Name : Yada Kishan Mother's Name: Padma Date of Birth : 28h August,1987 Sex : Male Marital Status : Married Languages Known: English, Hindi , Telugu and Tamil. I hereby declare that all the information provided by me in this application is factual and correct tothe best of my knowledge and belief. Yada Vinay Kumar