Career Objective

To extend my abilities to an organization which provide a wider scope, opportunity and environment to exercise my skills, and aspiring to take up challenging assignments, which demands high degree of analysis, creative and soft skills and there by prove my-self as highly skilled professional.

Strengths

Competent, enthusiastic, highly motivated with extensively varied exposure and good communication skills and solid a team player with an ability to immediately adapt to the changing technologies and trends. Ability to work unsupervised.

Educational Qualification

· Master of Science in Organic Chemistry,

Sri Venkateswara University,

Nellore,

Andhra Pradesh,

India.

· Bachelor of Science (Maths, Physics & Chemistry),

Sri Venkateswara University,

Nellore,

Andhra Pradesh,

India.

Additional Qualification

· Qualified member of AIC (Associate-ship of Indian Chemists), Calcutta, India

· ISO 9001:2008 Certification of Lead Auditor from IRCA, UK

· Diploma in Quality Control & ISO 9000, NILEM, Chennai, India.

· Diploma in Computer Applications, Hyderabad, India.

Total experience 26 years

· 1994 –1999: As a Chemist-QC in Krebs Bio chemicals ltd., Nellore, AP.

· 1999 – 2001: Sr. Chemist-QC in Avon Organics Ltd, Hyderabad & Solapur.

· 2001 – 2006: Sr. Chemist to Executive in Sri Krishna Pharmaceuticals Ltd. Hyderabad

· 2006 – 2013: Sr.Executive-QC to Sr.Manager-QU in Krebs Bio chemicals ltd, Nellore

.

· 2013 – 2018: Manager- QC in Hy-gro Chemicals & pharmatek Pvt.Ltd., Hyderabad

· 2018 – 2018: Sr.Manager- QC in Azico Biophore pvt- ltd, Visakhapatnam

· 2018 – Till date: Sr.Manager- QC in Hy-gro Chemicals & pharmatek Pvt.Ltd., Hyderabad

Audits Faced (Directly & indirectly)

· Regulatory Audits: USFDA, TGA, EDQM, KFDA and WHO

· III party audits: ISO9001, OSHAS, EHS, Rephine and Gempex GMBH

· Customer audits:Dr.Reddy’s, Mylan, Aurobindo pharma, Cipla, P&G, GSK, Cadila, Ranboxy and Unimark Remidies etc.

Hands on Experience

· Physico-chemical & instrumental analysis of raw material, in-process, intermediate and finished products Including Microbiological analysis.

· Preparation & review of all kind of SOP’s, documents.

· GLP Maintenance in Quality Control

· Method developments, Method Validations, Method Transfers.

· Equipment Qualifications.

· Works distribution and allotment.

· R&D samples analysis.

· Stability studies management as per ICH guidelines

· Control samples management.

· Approval of the materials (Raw materials, Finished products).

· Conducting training programme to the QC staff like Induction. On job & GMP training.

· Instruments handled like HPLC, HSGC, FTIR, UV-spectrophotometer, Autotitrator, Auto polarimeter, Refractometer, Ion Chromatography, Inductive coupled plasma – OES and Particle size analyzer etc.

· Supporting to provide the documents in DMF submissions.

· Participating in the man power recruitment.

· Review and up gradation of the SOP’s as per current guidelines.

· Review of Standard Test Procedures and Test Protocols.

· Participating in the preparation of quality manuals as per ISO 9001:2000.

· Organizing the trainings as Training coordinator on various guidelines such as Q7A, Q1A etc.

· Monitoring and controlling of online documentation

· Performing the internal & external audits.

· Handling of market complaints, return goods and non-conformances wherever applicable.

· Looking after to do any change through the change control procedure and to follow the deviation procedure if any deviation happens.

· Monitoring and closing of all instrument calibrations as per annual schedule.

· Involving in Vendor Qualification.

· Qualifications (DQ, IQ, OQ & PQ).

· Investigation of OOS.& OOT.

· Risk analysis

· Incidents investigation and follow up till closing of CAPA

· Risk assessment on elemental impurities as per ICH guidelines and nitrosoamines risk assessment study as per US and EMA guidelines.

· GTI study as per ICH Q7M.

Validations:

· Participating in Process validations.

· Purified water validation.

· Process validation protocol and report review.

· Cleaning validation protocol and report review.

· Participating in Blending validation.

· Participating in Drying validation

Personal Details

Name Koppala Venkateswarlu

Fathers Name K. Subrahmanyam

Date of Birth 10-04-1972

Sex Male

Nationality Indian

Marital Status Married

Permanent Address North Rajupalem, Dinne(Nagamma complex), Kodavalur Mandal

Nellore district, Andhra Pradesh, India.

Present Address 254G, Janapriyanagar, Phase-II, Miyapur, Hyderabad, Telangana, India.

Mobile No. +91-807*******

Languages English, Hindi & Telugu

Declaration

I hereby declare that the information furnished above is true and correct to the best of my knowledge and belief.

K.VENKATESWARLU

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