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.
Capabilities to handle the challenges of pharmaceutical industries of data integrity and
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.
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 SOPS & 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.

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.
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