R.

DASARATHARAMI REDDY Mobile: +91 9959046173

Email: rdasaratharamireddy@gmail.com
Seeking challenging assignments in Quality Assurance with a high growth oriented organisation of repute

PROFESSIONAL SYNOPSIS

A result driven professional with over 9 years of experience in the area of Quality Assurance and manufacturing; currently designated as Deputy Manager Quality Assurance with Biological E. Limited, Hyderabad.

Expertise in managing Lot release, Documentation, Process Validation, Training, and Inspection activities of quality assurance and managing the project documentation activities related to the products to be developed.

An effective communicator with good negotiation, relationship management and problem solving skills.

Functional representative and interface for external audits.

CORE COMPETENCIES Quality Assurance

Monitoring quality systems & compliance with pre set standards; handling overall process documentation activities and maintaining requisite documents to ensure complete inprocess quality & improvement in process capabilities.

Ensuring the implementation of countermeasures planned on the basis of gap analysis. Acting as Internal auditor and hands on participation of external audits.

MIS / Documentation

Formulating MIS reports relating to Production Operations & Quality operations to the top management for facilitating the decision making process.

Overseeing the preparation, review and approval of Documents such as SOPs, BPR, Specifications, Master Formulae, Validation Protocol, Cell bank history documents, and Validation summary reports.

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Man Management

Leading / motivating the working people ensuring their career development. Imparting training to various skilled & non skilled employees, thereby ensuring optimum performance.

ORGANISATIONAL CONTOUR Since May 2010 to till date at Biological E. Limited, Hyderabad as a Deputy ManagerQuality Assurance Since May 2009 to April 2010 at Biological E. Limited, Hyderabad as an Assistant Manager-Quality Assurance, Since April 2007 to April 2009 at Biological E. Limited, Hyderabad as an Executive Quality Assurance. Key Deliverables

Managing the quality activities and initiatives covering various aspects of Quality Assurance.

Managing/co-ordination for the project activities related to Bulk products (Diphtheria, Pertussis, Tetanus, Recombinant Hepatitis B and Hib Polysaccharide) as per cGMP requirements.

Tracking of the project milestones by establishing and managing tracking system; imparting training and guiding the team for the batch release activities.

Major Attainments

Implementation of Quality Systems as per compendia requirements Integral part in setting up of QA for a multi product facility. Successfully handled Audits / Inspections as below o WHO Prequalification Audit for Liquidpenta (DTwPH+Hib) as functional team lead in 2012.
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WHO Prequalification Audit for Recon Penta (DTwPH+Hib) as functional team lead in July 2010 and June 2011.

Successfully handled the Invima audit ( October 2011) as functional team lead.

o Successfully handled the JFDA audit ( April 2012) as functional team lead.
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Successfully handled the customer /JV audits (GSK, Novartis, Ministry of Suadi, Ministry of Turkey) Page 2 of 3

Actively co-ordinated in Product Summary File (PSF) Documentation and Training activities.

Participated in internal audits & Management Information Systems. Handling of Change control, Out Of Specifications (OOS) and Deviations. CAPA management Preparation and review of Annual Product review reports.

Nov03 April07 at Bharat Biotech International Limited, Hyderabad Nov03 Nov04 Dec04 Nov05 Dec05 April07 Key Deliverables

Trainee Upstream and Media preparation Junior Executive - Production Executive - Production

Preparation of Documents such as SOPs, BMR, Master Formulae.. Overseeing the preparation of databases for the various activities of the documentation system.

Co-ordinating technology transfer activities.

Major Attainments

Played a key role for audit preparation for WHO pre-qualification for Recombinant Hepatitis B Vaccine.

Hands on experience in handling of WHO Pre-qualification audit.

ACADEMIA

M.Sc. (Biotechnology). B.Sc. (BZC).

I.T. Skills: MS Office (Word, Excel, PowerPoint and MS Visio) PERSONAL PROFILE Date of Birth Linguistic Abilities Permanent Address 1st June 1979 English, Hindi and Telugu HNo.:2-113,MainRoad, P.Kotakonda(Vill & Post), Yerukala Cheruvu ( Via),Kurnool (Dist), Andhra Pradesh-518225.

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