Shailaja G R Contact No.: +91-9790964788

SHAILAJA G R
Contact No.: +91-9790964788

E-Mail: pabbasailaja@gmail.com
A result oriented professional, in quest of senior level challenging assignments in Quality Control with a leading organization
of repute in Pharma industry preferably in Chennai
PROFILE SUMMARY
A Qualified Professional in pharmaceutical industry with 7 years of experience in Quality control, Stability studies, Process
improvement and Quality Assurance activities
Last associated with Gland Pharma Limited, Dundigal, Hyderabad as Senior Chemist - QC
Skilled in developing in-house analytical methods and standard testing procedures for use by QC personnel; monitoring &
controlling of quality standards as per industry requirements
Adept at supervising analytical work & documentation as per the requirement of specialty Pharma industries
Sound knowledge of ISO implementation, conducting stability studies, preparation of stability protocols & reviewing SOPs
and GTPs
Deftness in reviewing documents /analytical reports thereby ensuring documentation as per guidelines and preparing
Analytical technology package for the developed processes
An effective communicator with good analytical, problem solving and interpersonal skills
CORE COMPETENCIES
Conducting tests and the inspections to ensure that the products developed are in compliance with the pre-set technical
specifications
Reviewing the operational practices, identifying the areas of obstruction/ quality failures and advising on system and
process changes for qualitative improvement
Preparing specification, SOPS and relevant documents; supervising analytical work & documentation as per industry
regulations for smooth operations
Coordinating with the QA/ QC personnel at various manufacturing sites for implementation of the current / revised
standard testing procedures and specifications for new products
Directing, leading & motivating workforce and imparting continuous on job training for accomplishing greater operational
effectiveness/ efficiency
WORK EXPERIENCE
Dec08-Oct'10
Gland Pharma Limited, Dundigal, Hyderabad as Senior Chemist - QC
Role:
Verified consumption records of working standards and reference standards
Handled acquisition, verification and maintenance of reference standards
Prepared, standardized and maintained of working standards
Oversaw daily verification of calibration status of equipments
Looked after calibration of equipments like UV-Visible Spectrophotometer, Polarimeter, Autotitrator, Karl-Fisher
Apparatus, IR, Refractometer, pH meter, Conductometer and Melting Point Apparatus
Prepared and standardized volumetric solutions and reagents SOPs
Analyzed raw materials, intermediate samples, finished products and stability samples
Contributed & participated in customer audits of M/s. CIPLA, M/s. DR. REDDYS Laboratories and FULFORD
Dec05- Nov08
M/s. Uni-Sankyo Limited, Gaganpahad, Hyderabad as Executive QC & QA
Role:
Analyzed raw materials, packing materials and finished products for smooth process flow
Responsible for Product Dossier Preparation & SMF Preparation.
Served as Deputy Management Representative and assisted in ISO and maintaining of records
Oversaw tasks related to Technology Transfer of the product to the concerned location -USL Lote and Akin Laboratories
Participated in customer audits of M/s ALEMBIC, M/s GLENMARK, M/s LUPIN, M/s. INTAS and M/s. SVIZERA
Reviewed and issued SOPs, specifications, GTPs, STPs, BMR and BPR
created stability protocol for new & existing products and conducted stability studies
Merit of facing ISO, WHO audits successfully
May03- Nov05
M/s. ESPI Industries Private Limited, Uppal, Hyderabad as Junior Executive QC
Role:
Analyzed raw materials, in-process samples and finished products
Prepared & standardized volumetric solutions and maintained records for the same
Handled calibrations of instruments like Disintegration Test Apparatus, Dissolution Test Apparatus, Friability Apparatus,
pH Meter, Conductometer, UV-Visible Spectrometer & Polarimeter
Looked after stability studies of new & existing products of Oral Dosage Forms
Participated in Audits of M/s. Wyeth Limited, M/s. Dr. Reddys Laboratories, M/s. Pfizer, M/s. Ranbaxy and M/s. NPIL
Highlights:
Served as Deputy Management Representative for obtaining ISO 9001:2000 Certification in M/s. Uni-Sankyo Limited
Served as team member for achieving WHO-GMP (DCGI) Certification
Successfully completed online application and submitted dossiers for registration of products for Sudan
TECHNICAL PURVIEW
Well versed with:

o Analyzing different raw materials, oral dosage forms, suspensions, syrups, dry powders and injections (Small Volume
Parenterals and Lyophilized Products) as per Pharmacopoeial Methods/IH Methods
o Preparing stability protocols, scheduling & analyzing of various products as per ICH guidelines
o ISO implementation and documentation
o Microbiological assays of Lactic Acid Bacillus, Lactobacillus Acidophilus and Vitamin B12
o BET & Sterility tests
o Maintaining calibrations, instrument log books and training records
o Reviewing SOPs, Specifications, STPs and GTPs
EDUCATION
2011
2002
1998
1996
Advanced Diploma in Validation Techniques for Pharmaceutical Industries from Annamalai

University, Tamil Nadu
B.Pharm from G. Pulla Redddy College of Pharmacy, Mehdipatnam, Hyderabad
12th from Ideal Junior College, Dilsukhnagar, Hyderabad, Andhra Pradesh
10th from Madapati Hanumantha Rao Girls High School, Narayanaguda, Hyderabad
IT SKILLS
Well versed with MS Office (Word, Excel & PowerPoint), Windows 7/Vista /XP
PERSONAL DETAILS
Date of Birth:
Languages Known:
Contact Address:
9th March, 1982

English, Hindi and Telugu
H. No. 5-16/A, S. R. Castle, Michael Gardens, Ramapuram, Chennai- 600089, Tamil Nadu

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SHAILAJA G R

Contact No.: +91-9790964788

Well versed with:

Advanced Diploma in Validation Techniques for Pharmaceutical Industries from Annamalai

9th March, 1982

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