Objective :
Seeking a challenging and responsible research and development position that gives me an opportunity to implement my pharmaceutical work experience with a prospect of responsibilities and career growth.
Key Competence :
Research Skills;
Computing;
Problem solving;
Reporting;
Collaborating;
Prioritizing;
Lateral Thinking;
Implementing;
Team work;
Planning;
Excellent interpersonal, communication, managerial and organization skills.
Areas of Expertise :
About 5 years of experience in the following areas :
Design and implementation of systems to support cGMP compliance;
Quality auditing;
Validation quality assurance oversight, including developing quality standards for validation and approval of protocols and reports;
Familiar with various manufacturing processes, process validation, technology transfer, documentation system, SOP’s, cGMP, GLP as well as FDA regulations.
Analysis of various dosage forms such as tablets (I.R. and E.R.), capsules ;
Instrument calibration such as that of HPLC, UV, IR, Dissolution apparatus, Karl Fisher apparatus, analytical balance etc;
Well versed in generation, maintenance and revision of SOPs, specifications, procedures, training, OOS investigations, and other documentation systems;
Wide exposure to quality control, quality assurance, manufacturing, method development and validation, compliance and regulatory areas in a pharmaceutical manufacturing environment;
In depth knowledge of drug stability studies;
Proficient with common computer software, Waters Empower software, word, excel etc;
Faced audits of US FDA, WHO/PEPFAR, ANVISA (Brazil), MHRA, MCC (South Africa), TGA, JPMA etc.
Training on Data Integrity Concepts & Good Documentation by Dr. Ronald F. Tetzalff (PAREXEL CONSULTING FLORIDA, USA). Ex USFDA Investigator.
Team member Training organization.
Well versed in all modern instrumentation such as :
HPLC instruments such as Waters, Shimadzu, Agilent, Perkin Elmer;
Dissolution Apparatus and Auto Dissolution Apparatus (Electrolab, Distek);
UV/ Visible spectrophotometer (Shimadzu, Perkin Elmer);
Gas Chromatography such as Agilent, Perkin Elmer;
Karl Fischer Auto-titrator (Metrohm);
Tapped Density Apparatus;
IR spectrophotometer;
Friability Apparatus;
Disintegration Apparatus and various other Analytical Techniques.
Work Experience :
Research Associate : (From March 2008 till May 2010):
As a Research Associate in Jubilant Organosys Formulation Division, R & D centre in Noida, UP, India my job profile is summarized as below :
Review analytical data of method development, validation, related to techniques such as HPLC, UV, Dissolution Apparatus, IR, GC etc.
Review and edit method development, validation, technology transfer protocols and reports.
Review of calibration data of various analytical instruments, working standard profiles and routine analytical data;
Assist in writing documents to ensure compliance with regulatory guidelines and applicable regulations.
Write QA Standard Operating Procedures (SOPs).
Managed and coordinated stability time points and testing of stability protocols ,designed standard stability protocols, reviewed stability data sheets, performed statistical evaluation, oversaw the validation and maintenance of stability chambers;
Perform analysis of formulation dosage form (IR and ER), whenever required for method development and validation;
Instrument calibration such as that of HPLC, UV, IR, Dissolution apparatus, Karl Fisher apparatus, analytical balance etc;
Review and discuss current practices, identify issues, and assist investigations, including CAPA;
Support quality and operations-related problem resolution;
Review all activities at Formulation Analytical R&D facility with respect to identifying any cGMP or Quality deficiencies in laboratory, validation systems;
Conduct and coordinate in internal QA audits;
Assist in implementing quality systems;
Provide training related to stability program, cGMP topics;
Conduct training courses of various instruments such as HPLC, UV, Analytical balance etc, Stability Testing, Method Transfer and Method Validation etc.
Stability officer (From July 2005 to March 2008) :
As a stability officer I started my career with Ranbaxy Labs Ltd, Paonta Sahib, HP, India.
My strong base in analytical techniques was built here. My job profile at Ranbaxy labs Ltd is summarized as follows :
Performed analytical tests using lab instruments, such as HPLC, UV/VIS, IR on stability samples;
Recording and summarizing experimental data according to guidelines and protocols;
Learning and following all existing SOP / GMP / GDP / GLP;
Using spreadsheets and word processing software to trend product integrity and keeping records up-to-date;
Testing of Stability Products; evaluation of stability results and write stability reports;
Experienced in Stability Program as per ICH guidelines;
Prepare OOS / OOT/analytical deviation reports when required;
Instrument calibration such as that of HPLC, UV, IR, Dissolution apparatus, Karl Fisher apparatus, analytical balance etc;
Performed Technology transfer of methods from R & D centre to plant site;
Served as the stability expert for research and development and represented stability issues;
Review of stability data, Technology Transfer documents;
Coordination in organization of training sessions on topics related to cGMP, stability program; technical trainings such as HPLC, UV, Dissolution apparatus etc;
Gained in depth knowledge of Quality Assurance , Quality Control, Stability, manufacturing sites;
Faced audits of US FDA, WHO/PEPFAR, ANVISA(Brazil), MHRA,MCC (South Africa), TGA, JPMA etc;
Training on Data Integrity Concepts & Good Documentation by Dr. Ronald F. Tetzalff (PAREXEL CONSULTING FLORIDA, USA). Ex USFDA Investigator.
Education :
Pursued certificate course in Pharma Drug Regulatory Affairs from BII institute, Noida, UP, India;
Obtained Msc Degree in Chemistry (Organic Chemistry specialization) from HP University, Shimla, HP, India;
Obtained Bsc Degree from St Bede’s College, Shimla, HP, India.
Declaration :
I hereby confirm that the information furnished above is correct to the best of my knowledge.
Date : ___________
Place : ___________