1. Curriculum Vitae
RAJENDRA BALASO KOLAPE
Email :rajendrakkolape@yahoo.com Mobile No.:08108269129/09167211319
Carrier Overview
Post Graduate in Chemistry with 13.5 years of experience in Quality Control with experience in raw material
analysis, stability analysis, finished product analysis of tablets, topical preparations, liquid orals, ophthalmic,
nasal spray, respiratory solution. Method transfer, Analytical method Development and Analytical method
validation. Equipment lifecycle management of lab instruments.
Career Objective
To excel in analytical and related research fields enabling business and safeguarding patient health.
ACHIEVEMENTS:
♦ Johnson and Johnson
- Cleaning Method development and qualification set-up
- Initial Lab set-up (qualification of new instruments)
- Intrinsic stability and solubility study of NME
(Performing intrinsic stability and solubility study, Excipient comparability study by DSC and TGA, Particle
size characterization study by Malvern)
Experience:
Group Leader – Clinical Release & Stability
Executive, Analytical Development at Janssen
(A Division of Johnson & Johnson), Mumbai
(September 2007 till date)
Senior Officer, Quality Assurance/Quality Control
at Ranbaxy Labs Ltd., Goa
(October 2005 to August 2007)
Officer, Quality Assurance at Cipla Goa
(Nebumed)
(October 2002 to September 2005)
Job Profile:
• Hand on experience in team management of stability and production supporting quality control
Team
• In depth knowledge about quality management systems and Quality control.
• Excellent analytical, troubleshooting skills to achieve goals within timelines
• Involved in audits of external vendors and act as auditee during regulatory audits.
• Handling of quality records (Event, deviation, OOS, OOT, COC and CAPA) through electronic
systems.
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2. • Co-ordination and collaboration with Production, Quality Assurance as a single point of contact
for the laboratories
• Coordination with global specification development group for revision and creation of
specifications.
• Coordination with CRO lab for the timely availability of test results after analysis
• Review of Laboratory Data for accuracy, completeness & compliancy as per ALCOA principles
• Perform Pharmaceutical Stability Sample Analysis as per ICH and various regulatory
requirements & generate Data and prepare Reports in accordance with Approved Procedures.
• Cleaning Analytical method validation, Analytical method Development, Column equivalency
study
• Analytical support to cleaning validation/Cleaning verification activities.
• Review of cleaning validation, stability protocol and reports.
• Lifecycle management of instruments and equipment’s. (Qualification and Calibration).
• Coordination and conducting of analytical methods Transfer Activities.
• Risk assessment as per ICH guidelines IQ, OQ, PQ, of Instrument, Calibration of instruments
like UPLC, HPLC, DSC, TGA, UV Spectrometer etc.
• Perform intrinsic stability and solubility study, Excipeint comparability study by DSC and TGA,
Particle size characterization study by Malvern.
• Imparting technical training to new joinees.
• Documentation (Preparation of Specifications, SOPs, COAs and Protocols)
• Stability Sample Management, chamber mapping study
• Support to Regulatory for DMF filings
• Sampling analysis and release of raw materials and finish product.
Software exposure:
Empower-3, Chromoleaon, Eris for document preparation, Docspace Manager, Qpace, E-track
wise system and elims etc.
Audit exposure:
Exposure of various regulatory authority audit like USFDA Audit, UNICEF Audit, NDA Uganda,
MCA Inspection, TGA Audit, WHO (GMP Audit), ANVISA Inspection (BRAZIL), Uganda Authority
Inspection, Tanzania Audit, Leo Pharma Audit. EMA, ERC and Biogen Audit
Academic credentials:
Master of Sciences in Chemistry from Shivaji University of Kolhapur, First Class (Year 2002)
Approved Competent Technical Staff in Chemical & Instrumentation – Maharashtra FDA
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