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Transcript of Updated Rambabu 01082011
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BIO DATA
Name : Rambabu Komati
Permanent Address : Blis@Venkateswara Residency,
Plot No. 103,
Bachupally,
Hyderabad.
Andhra Pradesh,
India.
Residence No : 91-8801061949
Mobile No : 00 91 8142222563 & 00918801061949
E Mail : [email protected]
Date of Birth : June 6th 1977
Qualifications : 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
mailto:[email protected]:[email protected] -
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Career Graph:
November 2009 to current : Corporate -QA Dy.Manager in Vivimed Labs Limited
September 2008 to October 2009 : Dy.Manager-QA in Kamud Drugs Pvt. Limited
Maharashtra
April 2007 to September 2008 : Asst.Manager Vivimed Labs Limited, Bidar, Karnataka.
Dec 2001 to April 2007 : Sr.Executive Natco Pharma Limited, Hyderabad.
April 1999 to Dec 2001 : Sr.Chemist in production dept. Divis Laboratories
Limited, Hyderabad.
Achievements / Participations :
Audits faced for Integrated Management Systems (QMS, OSHAS, EMS) an
SA 8000: 2008.
GSK, B Brown, P&G, J&J, Reckitt Benckiser audits, Dr.Reddys, GMP audit faced in Vivim
Labs Limited
Internal Quality and Environmental auditor certified by TUV
Actavis, Medochemie, Frencis-Kabi South Africa, Claris life science Customer aud
successfully faced in KAMUD DRUGS Pvt. LIMITED
One of the leading team members who coordinates forUS 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
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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 annu
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.
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Follow up all audit reports for completion of corrective actions and ensure timely closure of aud
reports
Planning, organizing and monitoring day to day activities
Planning and conducting the training activities for GMP implementation and maintenance training records
Personal Details:
Name : Rambabu Komati
Date of Birth : 6th June 1977
Languages Known & Speak : English, Telugu, and Hindi
Reference:
1.0 Dr.Prem R Goel,Director Technical
PAN Drugs Limited
Baroda, Gujarat, India
Cell No. 09327316198
2.0 Mr.T.Rama Rao
Manager Production
Vivimed Labs Limited
Unit-II, Bonthapally,
Medak District
Cell No. 9985410414
mailto:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]
