BIO DATA

Name Permanent Address

: :

Rambabu Komati Blis@Venkateswara Residency, Plot No. 103, Bachupally, Hyderabad. Andhra Pradesh, India.

Residence No Mobile No E Mail Date of Birth Qualifications

: : : : :

91-8801061949 00 91 8142222563 & 00918801061949 rambabukomati@gmail.com June 6th 1977 M.Sc. [Chemistry] B.Sc [Chemistry] Diploma in Quality Assurance and ISO

Certifications

Internal Quality and Environmental auditor (QMS & EMS) certified by TUV

Technical Qualifications

English Type writing lower grade with first class MS office

Career Graph: November 2009 to current September 2008 to October 2009 April 2007 to September 2008 Dec 2001 to April 2007 April 1999 to Dec 2001 Limited, Hyderabad. Achievements / Participations : Audits faced for Integrated Management Systems (QMS, OSHAS, EMS) and SA 8000: 2008. GSK, B Brown, P&G, J&J, Reckitt Benckiser audits, Dr.Reddys, GMP audit faced in Vivimed Labs Limited Internal Quality and Environmental auditor certified by TUV Actavis, Medochemie, Frencis-Kabi South Africa, Claris life science Customer audits successfully faced in KAMUD DRUGS Pvt. LIMITED One of the leading team members who coordinates for US FDA audit in NATCO Pharma & Divis Laboratories. Tasks Performed: Master Documents Preparation: Preparation of Site Master file Preparation of Quality Manual Preparation of Validation Master plan Preparation of Master formula record in co-ordination with R&D department Preparation of USDMF & EDQM COS Preparation of Technical files : : : : : Corporate -QA Dy.Manager in Vivimed Labs Limited Dy.Manager-QA in Kamud Drugs Pvt. Limited Maharashtra Asst.Manager Vivimed Labs Limited, Bidar, Karnataka. Sr.Executive Natco Pharma Limited, Hyderabad. Sr.Chemist in production dept. Divis Laboratories

Documentation associated with Validation and qualification: Preparation of protocols and reports and review of generated results for the following: Equipment qualification and calibration Process Validation Cleaning Validation Drying validation MPR & APR (Monthly & Annual Product Reviews)

QA Activities Preparation of Batch manufacturing records as per master formula record. Preparation of schedules and carry out the self inspections as per cGMP requirements Review of filled BMRs, BPRs Preparation of Integrated Management Systems documents and SA 8000: 2008. Assisting the superiors for Customer Audits and Regulatory Audits Preparation and Review of SOPs in co ordination with different users Handling of change controls, Deviations Compilation of Customer questionnaires. Conducting the vendor audits for Key raw materials Preparation and review of approved vendor list and vendor annual performance Data Preparation and Review of Protocols, specification and test methods Preparation and Compilation of data for the preparation of Monthly Product Reviews and annual product reviews Involve in visual checking of cleaned manufacturing equipments for clearance. Coordinate the archival of documents Handling of customer complaints and return goods & Product Recalls. Distribution new/ revised of SOPs to respective department and with drawn the retired Sops Regularly review of production, Quality control, Maintenance and stores records.

Follow up all audit reports for completion of corrective actions and ensure timely closure of audit reports

Planning, organizing and monitoring day to day activities Planning and conducting the training activities for GMP implementation and maintenance of training records

Personal Details: Name Date of Birth Languages Known & Speak Reference: 1.0 Dr.Prem R Goel, Director Technical PAN Drugs Limited Baroda, Gujarat, India drpremrgoel@gmail.com, drpremrgoel@rediffmail.com Cell No. 09327316198 Mr.T.Rama Rao Manager Production Vivimed Labs Limited Unit-II, Bonthapally, Medak District Cell No. 9985410414 rrtallam@gmail.com : Rambabu Komati : 6th June 1977 : English, Telugu, and Hindi

2.0