Quality Control Manager

SUDHEER JENJETI

Address: *-***/*,

Near Alivel Mangamma Temple, Hashminagar,

Pendurthi, VISAKHAPATNAM - 530051

Contact : +91-964*******, E-Mail: z. **********@*****.***

To become an integrated personnel in the quality management of specialty chemicals, pharmaceuticals

PROFESSIONAL OVERVIEW

Since Nov 2011 with SNF (India) Pvt.Ltd. as Deputy Manager-Quality Control

Maintain the quality system and ensure compliance with quality standards as prescribed by

ISO 9001 and ISO 17025

Ensure data and instrument integrity, and report any atypical sample condition, analytical results,

and equipment irregularities

Responsible for adherence and improvement of laboratory safety

Drafting/revising/reviewing SOPs, methods, specifications, training modules and IQ/OQ protocol;

translating methods;

Training new specialists and following up on the corresponding specialist’s work in the

Laboratory.

Participate in new, corporate and local projects and take part in the validation work throughout the

plant, in which Laboratory resources are required.

Be responsible for the sampling and testing of utilities/raw materials, in-process samples, semi-

finished/finished products and primary packaging materials as well according to designated task.

Regulatory Requirement for analysis issues.

Ensure that all the raw data during the testing are correctly recorded down and all results or

testing investigation summary are made completely and timely.

Monitoring PCB and regulatory guidelines

Responsible for the instrument/equipment management in Laboratory, i.e. ensure that each

individual instrument/equipment archive be maintained properly with integrated life-cycle

documents; approve Laboratory Calibration Sheet and calibration results;

Submission of daily quality report and highlighting any deviation to process.

Managing the dispatch work of the finished product.

Involve in trending of data and identify changes in quality indices

Dec 2009 -Oct 2011 with Jubilant Organosys Ltd., Mysore. as Senior Officer - Quality Control

Update Laboratory instrument/equipment Calibration Matrix whenever necessary; scheduling

monthly calibration. Ensure that all instrument/equipment Calibration in Laboratory are executed

adhering to the schedule

Follow-up and ensure the implementation of instrument/equipment IQ/OQ/PQ.

Before assigning any responsibility, to ensure that specialist is trained and have relevant

qualification first and keeping the document in archival.

Ensuring compliances to all Quality Control activities with cGMP regulations, regulatory and

other requirements for Finished Products, Stability, Raw Materials, Packaging Materials sample.

API and semi-finished/finished products in compliance with regulatory authorities as appropriate

in the host country.

Ensure that all the data has been correctly entered into the data books and all data and corrections

are properly justified.

Work in line with norms of US FDA, MHRA, EDQM, TGA, WHO,ANVISA and other

regulatory markets

Co-ordination Out of specification (OOS) investigation and reporting,review the Root Cause

Analysis (RCA) and identify investigation gaps and to prepare CAPA(Corrective action and

preventive action)

Review the audit trails of the laboratory equipment and identify any duplicates. Document and

justify the incident.

Liable for maintenance of standards & impurities and controlling the analysis.

Sampling, analysis and approval of Finished API

Sep 2007- Nov 2009 with Shasun Chemicals and Drugs Ltd., as Sr. Executive –Quality Control

Sampling and analysis of raw material

Preparation, standardization and maintenance of volumetric solutions

Residual Solvents analysis and reporting

In process analysis

Sampling and analysis of Finished API

May 2005 – Sep 2007 with Aurobindo Pharma Limited, Pydibhimavaram as Senior Chemist – QC

In process analysis and Chemical Analysis

KNOWLEDGE PURVIEW

Waters 2695 – HPLC System with UV & PDA Detector.

Shimadzu – 2010, 2014, Agilent, Perkin Elmer - Gas Chromatographs.

Shimadzu UV Spectro – Photometer with PDA detector

FTIR (Perkin Elmer).Bruker (Opus Software)

Metrohm Auto Titrators.Tinet Software, Tiamo Software

Autopol IV- Polarimeter.Autopol-V Polari meter

Brookfield Viscometers

Malvern Mastersizer

Karl Fischer Apparatus

Melting range apparatus

TECHNICAL SKILLS

Possess knowledge of C language, MS Office, Windows. QC Activities Related Software ( SAP,Wings)

ACADEMICS

M.Sc. (Organic Chemistry) from Government Arts college,Rajahmundry(Andhra University)

qualified out in 2003 With 66 %

Qualified bachelor’s degree, B.Sc. (Mathematics, Physics and Chemistry) in Dr.V.S. Krishna

Govt. Degree College, Visakhapatnam in 2000 with 77 %.

PERSONAL DOSSIER

Pass port Number : G 2615351 (Valid till 11/07/2017)

: 15th August, 1980

Date of Birth

Languages Known : English, Hindi, Telugu, Tamil and Kannada

Hobbies : Traveling, listening to music, reading journals

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