Rajnikanth Rengaraju

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rajinikanth rengaraju
rajinikanth rengaraju

Locality: Chennai Area, India
Summary: Rajiniaknth Rengaraju has expertise in the field of Quality assurance and regulatory affairs. The skills and knowledge acquired during my carrier is implementation of GMP to acquire WHO PQ accreditation. Have knowledge about the implementation of regulatory functions as per USFDA. In the field of QA I have implemented the quality system with necessary documentation, also implemented validation activities like (VMP, FAT, SAT and other qualification cascade of the Equipment, Utility and Facility) process of the product, media fill, cleaning, shipment and sterilization process. Involved in the internal and external audit to identify and rating the quality system in compliance with WHO GMP. Triggering the investigation of the OOS, OOL and any other deviation & incident observed in the facility and CAPA is prepared and follow-ups taken to closure the NC. Involved in the change management system to controlling the changes and reliable regulatory advice is provided to make necessary approvals before any critical change. Overseeing the Personnel training and qualifying the trainer. Have knowledge about the product complaints (like Quality and ADR). Review of analytical method validation as per the ICH Q2 & stability study as per ICH Q5C. Review of MPCR, BPCR and release of finished product to the market. Review of drawings and preparation of APQR for the DS & DP. Regulatory exposure like preparation of DMF, CTD, filing INDA and NDA. Successfully faced the external audit of DCGI, COPP and ISO 14001: 2000. Have knowledge of designing facility for biologics and bio-pharma as per the GMP requirement. My objective is thriving to put the system in the organization in a right way to improve the quality and avoid the loss. I am interested in working with reputed pharma having /pursuing USFDA, MHRA etc.
Current: Asst. Manager at Shasun, Biotech Unit
Education:  Bharathidasan University Bio Chemistry (1999-2001) 
 Madurai Kamaraj University Biochemistry (1996-1999) Top performer in the Studies
 IPH&H, Delhi DMLT (1994-1995) 

Industry: Pharmaceuticals
Skills: Quality Assurance - Validation - (Sterile and Non Sterile)
Experience: Shasun, Biotech Unit (Public Company; Pharmaceuticals industry): Asst. Manager,  (December 2009-Present) QA - Validation

Interests: Validation
Interests: career opportunities, consulting offers, new ventures, job inquiries, expertise requests, business deals, reference requests, getting back in touch
Groups: RAPS

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