1. CURRICULUM VITAE
KULDEEPAK SINGH NEGI
Manager (Corporate Quality Assurance)
Evolet Healthcare Pvt. Ltd., New Delhi
 +917042189230, +918006661611
 kuldeepak.negi@gmail.com
CAREER OBJECTIVE:
 Seeking innovative and challenging career in the professionally managed and dynamic organization,
which provides opportunity for development and greater responsibility to contribute towards
organization.
TOTAL PROFESSIONAL EXPERIENCE:
 9+ Years
WORK EXPERIENCE:
 M/S EVOLET HEALTHCARE PVT. LTD., DELHI
Designation: Manager- Corporate Quality Assurance
Work Period: Feb.2015 to till date
 M/S ELDER PHARMACEUTICAL LTD., DEHRADUN
Designation: Executive- Production (Injection)
Work Period: Nov. 2011 to Jan.2015
 M/S WINDLAS BIOTEC LIMITED, DEHRADUN
Designation: Sr. Officer – Production (Injection)
Work Period: Sep. 2009 to Nov. 2011
 M/S TORQUE PHARMACEUTICAL PVT. LTD. DERABASSI (PUNJAB)
Designation: Officer – Production (Injection)
Work Period: Aug. 2006 to Sep.2009

2. FDA APPROVAL
 Approved chemist in Parental Preparation from Uttarakhand Government.
JOB RESPONSIBILITY:
Corporate Quality Assurance Manager
 Develop, implement, manage, audit and maintain quality systems to support commercial and
development activities for a virtual pharmaceutical.
 Audit of third party manufacturer site, contract testing lab, CFA (warehouse), tracking its CAPA &
Effective implementation.
 Complaint investigation and its documentation and prompt response to customers.
 Implementation of QMS in commercial quality function, through preparation of SOPs, Training, and
effective implementation
 Review and approve/reject any document that gives work instructions and set requirements such as
procedures, protocols, test methods, and specifications—including changes to these documents.
 Review and approve/reject production batch records and make the final decision to release a product
lot into commerce.
 Preparation of monthly report and escalation of pending issues, organize monthly QA review meeting.
 Coordinate and perform all vendor qualification and compliance audits on paper vs. practice.
 Perform batch release activities, including lot file compliance review.
 Provide oversight for Quality Control activities performed by contract testing laboratories and contract
manufacturing companies.
 Ensure that cGMP requirements and quality standards are recognized, understood and maintained
across the Company.
 Ensure in-process and finished products and processes conform to in-house policies and procedures as
well as other applicable regulations and guidelines.

3. JOB RESPONSIBILITY:
Production Activities:
 Overall responsibility to achieve monthly target through successfully execution of monthly plan.
 Fabrication, aseptic filtration and filling of small volume parental, dry injection, ophthalmic solution,
and ear drop
 Handling of washing machine, filling machine, autoclave, DHS, Tunnel and automatic optical machine
(Brevitee).
 Preparation & review of BMRs and BPRs.
 Preparation and review of SOPs.
 Training given to subordinate, operator and worker.
 Maintain housekeeping, area maintenance, personnel monitoring and personnel hygiene in aseptic area
 Effective utilization of disinfectant to control microbial load in clean area.
 Troubleshooting and rectification of formulation problems
 Reporting daily manufacturing and packing activity to production manager.
 Communication with interrelated departments
 Manpower utilization & handling.
Validation Activities:
 Performed the media fills activity.
 Performed the area validation, HVAC Validation, Process validation of Product.
 Performed the performance qualification of equipment’s.
a) Vial/ampoule washing machine
b) Depyrogenating Tunnel
c) Vial/Ampoule filling machine
d) Autoclave

4. PROFESSIONAL QUALIFICATION:
Qualification Institution University Year
B. Pharm HNB Garhwal University HNB Garhwal University 2006
COMPUTER SKILLS:
 Well Versed with MS- Word, Excel.
 ERP
 Proficient in information retrieval using Internet
PERSONAL PROFILE:
Name : Kuldeepak Singh Negi
Father’s Name : Late. Shri H.S. Negi
Date of Birth : 19 November 1987
Language Known : English & Hindi.
Marital Status : Married.
Nationality : Indian
Permanent Address : Vill. - Jondla
P.O. - Chopra
Dist. – Rudraprayag (Uttarakhand) Pin-246495
DECLERATION:
I hereby declare that the above information given by me is true and correct to best of my knowledge.
Date:
Place: (KULDEEPAK SINGH NEGI)