1. NITIN KUMAR
FARIDABAD,HARYANA (INDIA).Cell: +91 9953895722, Email Id-nitinkmr1987@gmail.com
PROFESSIONAL SUMMARY
Laboratory Technician with 6 years' work at world fifth largest pharma company (Sun
Pharma) which having dedicated, hard-working, reliable and accurate professionals.
Experienced with sound knowledge of method validation for various regulatory bodies of
US, Canada, japan and ROW.
Technically strong in technology transfer to plant.
Manager with demonstrated versatility in adapting to ever-increasing complexity in the
healthcare industry. Committed to providing quality pharmaceutical care as an essential link in
disease management.
Commitment to provide quality work with regulatory compliance to deliver safe and
effective drugs.
accuracy.
SKILLS
Laboratory work competency
Qualified in institutional pharmacy
Motivated self-starter
Experience in wet chemical & instrumentation
Sound knowledge of pharmaceutical guidelines
Coordinated with various departments and ability to handle adverse situation
Skilled in problem solving, investigation and risk mitigation through corrective & preventive
actions
Provide strategic leadership with cross-functional teams to plan and design research projects to
new products
Outstanding knowledge of laboratory procedures and handling of instruments like HPLC, UV
Spectrophotometer, Dissolution Apparatus & Other Analytical Instruments
Self-motivated, hardworking and goal-oriented individual with a high degree of flexibility,
creativity, commitment and optimism.
2. WORK HISTORY
QUALITY CONTROL EXECUTIVE- 10/2010 to 07/2016
ANALYTICAL TESTING SERVICES (SOLREX PHARMACEUTICAL COMPANY) A
UNIT OF RANBAXY LABORATORIES LIMITED- DELHI
. Physical, Chemical and Instrumental studies of Oral doses form like tablets, Capsules,
Ointment, Cream, liquid preparation, powders and sterile preparations.
· Liquid Chromatography Method validation, Method Qualification & Method
verification.
· Technology Transfer of Pharmaceutical products and Raw materials.
· Responsible for troubleshooting of sophisticated Instruments in analytical lab
· Stability studies like Accelerated, Intermediates and long term of Finished
Products as per ICH Guidelines.
· Analytical Method Validation (for Accuracy, Precision, Selectivity or Specificity,
Linearity and range, limits of detection, limits of quantitation, Robustness and ruggedness,
forced degradation) as per ICH guidelines.
· Preparation and Revision of SOP’S & Standard Testing procedure
· Designing of protocols (Validation and Stability).
· Handling of Change Control, Deviations and Corrective and preventive action (CAPA) .
· Reviewing & interpretation the method validation data.
. Handling of Out of Specifications (OOS) & Out of trending (OOT).
· Physical, chemical and instrumental studies of finished products.
· Calibration of Analytical instruments.
. Analysis of in-process samples, semi-finished samples and finished samples.
. Analysis of API and excipients.
3. RESEARCH SCIENTIST- 07/2016 to 12/2016
JUBILANT GENERICS LIMITED- NOIDA
· Analytical method evaluation for Vendors method
· Review method validation data.
· Preparation and designing of method validation protocols.
· Conducting experiments for equivalency studies of pharmacopeial and in-house
analytical methods
· Technology transfer to production site
· Assisting whenever is required in new generic product analytical method
development.
· Performed analytical testing in support of routine product optimization.
· Performing working standard qualification as per inhouse Standard testing procedure.
RESEARCH MANAGER- 12/2016 to PRESENT
SUN PHARMACEUTICAL INDUSTRIES LIMITED- GURUGRAM
. Analytical Method and Validation of API,intermediates and finished products as per ICH
guidelines.
. Preparation of method validation protocol.
. Review of method validation data.
. Analytical method verification and method qualification.
. Query response to different location.
. Technology transfer to plant location.
. Preparation of technology transfer protocol.
. Review technology transfer data.
4. ACADEMIA
Master of Pharmacy (M. Pharma)-2010 (Pharmaceutics) – Singhania University,
Rajasthan.
Bachelor of Pharmacy (B. Pharma)-2008, B.S. Anangpuria institute of pharmacy
Maharishi Dayanand University, Rohtak.
ADDITIONAL INFORMATION
Approved Pharmacist from Haryana state pharmacy council.
Successfully completed Project work titled “Formulation & Evaluation
of Buccoadhesive patch of Chlorpheniramine Maleate” under the supervision of Dr. Dabeer
Ahmed,HOD (Pharmaceutics) Singhania University Rajasthan
Personal Vitae
Date of Birth : 21-Mar-1987
Correspondence Address : Faridabad
Sex & Marital status : Male & Married
Nationality : Indian
Language known : Hindi, English.
Hobbies : Socializing, Sports, Listening to music, travelling.
Strengths : Adaptable, Determined, Responsible, Team Player
Nitin Kumar