Ajay Kumar has over 10 years of experience in the pharmaceutical quality assurance field. He has a background in process validations, cleaning validations, vendor qualifications, audits, and compliance management. Currently, he works as an Assistant Manager of Quality Assurance at Jubilant Generics Limited in Roorkee, where he handles activities such as cleaning validation, process validation, vendor management, and investigations. He has a B.Pharmacy degree from A.A.I-Deemed University and experience working with various pharmaceutical companies in both management and analytical roles.

1. A-49, VIPIN GARDEN
GALI No-8, EXT. UTTAM NAGAR
NEW DELHI-59
GSM: 9816786080, 9458943614
AJAY KUMAR E-mail-
kajay_111@yahoo.co.in
(Experience: 10 + Years)
PROFESSIONAL SUMMARY
 Collaborative development and innovations in pharmaceutical field.
 Pharma professional with 10+ Years of rich and varied exposure in regulated environment of pharmaceutical
Quality Assurance, 5+ years in management position in Tablet, Capsule, dry syrup, liquid as well as Parental.
Key strengths (Technical):
 Process validations, Cleaning Validations, Hold Time Study.
 Quality Management System viz Change management, Deviations/OOS/OOT Investigations, skills.
 Vendor Qualification, Quality Risk management, Stability Study, IPQA.
 Annual product quality reviews.
 Qualification (Water System, HVAC, Equipment, Facility etc)
 Market Complaint management, recalls.
 Audits (Internal & regulatory) & compliance Management.
 SOP development, Trainings.
 Data integrity / data reliability exposure.
 Exposure to consultants & remediation program
Other skills:
 Working knowledge of global softwares Trackwise, Documentum, LMS, Cleaning Validation Software,
SAP etc.
 Good hands on with computer MS office, Technical writing.
 Interpersonal relationship
 Honest & hardworking
 Good leadership
 Trouble shooting & mentorship
WORK EXPERIENCE
 Presently working in M/s Jubilant Generics Limited. As Asst. Manager Quality Assurance, at Roorkee (U.K.).
From Aug.2013 to till date.
 Worked with M/s Ranbaxy Laboratories Ltd. as Block In charge (QA) of Cephalosporin Block (IPQA, Batch
Release, Validation/ QMS), at Baddi Dist- Solan (H.P)-174103. From Jun. 2010 to Aug 2013.
 Worked with M/s Konduskar Laboratories Pvt. Ltd. as a Sr. Executive Quality (New Lab Setup), at Kolhapur
(Maharashtra) From: May 2009 to Jun. 2010.
 Worked with M/s Baxter India Pvt. Ltd. (US based MNC) as a Quality Associate (IPQA, In Process/Finished
product analysis/Document issuance/ Document Management) at Gurgaon (Haryana) From: Dec.2007 to May.
2009.
 Worked with M/s Albert David Limited as a QA/QC Analyst at Ghaziabad (U.P) from Dec.2006- Oct. 2007.

2.  Worked with M/s Vatsa Testing Laboratories as Analyst (Analysis of raw material, finished product, water
etc.) at Murthal, Sonipat Haryana from July.2006 to Nov. 2006.
EDUCATIONAL QUALIFICATION:
 B. Pharmacy From “A.A.I-Deemed University”, Allahabad (U.P.) 2006, 1st division (8.55 Out of 10. Grade
A)
 Paper Published in International Journal: - Paper published with International Journal Pharmacology online
"Investigation of Comparative Antimicrobial Activity of Aloe Vera gel and Juice”.
REGULATORY AUDIT EXPOSURE
 USFDA, MHRA, MCC, PMDA, ANVISA, KFDA, TFDA, UGANDA, etc.
JOB PROFILE
CURRENT JOB PROFILE AT JUBILANT LABORATORY LIMITED, ROORKEE
 Handling of Cleaning Validation.
 Handling of Process Validation and Hold Time Study.
 Handling of Vendor Management with respect to Raw and Packaging Materials.
 Active participant for Investigations with respect to Deviation, Incident, OOS, OOT, Market Complaint etc.
 Handling of Quality Management System (i.e. Change Management, Deviation/Incident/Market Complaint/OOS/
OOT/CAPA/ Internal /Self Inspection etc).
 Review of Stability Study Protocol and its Data against the Stability Commitment.
 Preparation and Review of SOPs, APQR, Risk Assessment.
 To ensure the CPV at the time of each batch Finished Product Release.
 Ensure appropriate testing and support methods validations are completed through extensive interaction with
Quality Control and R&D.
 Review the executed Batch Record/Master Batch Records (FO/MI & PO/PI), Art Work, SOPs and compliance
adherence calibration of IPQA equipment/Instrument.
KEY SKILLS AS PER CURRENT AND PREVIOUS EXPERIENCE
• Validation
Activities
: 1. Execution of validation activities (Process, Cleaning, Sterilizer, Water & HVAC
Qualification).
2. Preparation of VMP, Validation Protocols (i.e. Process/Cleaning Validation,
Environment Monitoring, Compressed air etc.) and its reports.
3. Sampling of process validation and cleaning validation.
• BMR & BPR : Preparation, issuance and review of BMR, BPRs, BOM etc.
• SOPs/Spec./STP : Review of SOPs/ Specification/STPs.
• Qualification : Qualification and re-qualification of equipment as per the schedule.
• Quality System : Handling of Change control, Deviations and all other quality system documents.

3. • APRs : Preparation of Annual Product Quality Review.(A.P.R)
• Stability Study : Monitoring of Stability study i.e. preparation of stability protocols, sample incubation,
sample withdrawal schedule, stability trends etc.
• Quality control &
Testing
: Handling of Calibration of Laboratories Instruments like-HPLC, UV, FTIR, AAS,GC
with Head Space, Testing of Raw materials, In process samples, finished products,
packing materials and Microbiological testing like-Sterility, Bacterial Endotoxin test,
Environmental Monitoring etc
• IPQA Activities : 1. Monitoring of IPQA activities at shop floor and reporting the non-conformance to
head QA, Batch Release in SAP, Deviation, CAPA implementation, Shop floor
Investigation etc.
2.To ensure CGMP compliance at all level of manufacturing activity
3.Collection of non-conformance from production floor and assure that corrective and
preventive actions are taken and documenting the same
4. To ensure the conformance of systems and work practices with the Standard
Operating Procedures
5. Calibration and preventive maintenance of IPQA lab equipments
• Project Stage
Experience
: Having experience of working in the project stage at Baxter India Pvt Ltd (Parental),
Konduskar Laboratories Pvt. Ltd and Ranbaxy Laboratories Ltd. (Solid and liquid
oral dosage form) Consequently having experience of QC lab setup, Purchasing of
Instruments, spares and other Lab aids, Water system qualification, HVAC qualification,
Area qualification (i.e. Micro lab, Sterile and Non Sterile process area etc.) and other
equipments qualification.
INSTRUMENTS HANDLED
 Special Handling of AAS. (Make-Perkin Elmer -Analyst 300)
 TOC Analyzer (Model - Sievers 900)
 UV- Spectrophotometer (Make- Shimazdu UV-1650,UV-1700,UV-1800)
 Auto-Polarimeter (Make - Rudolph Research Analytical-Autopol-IV & V)
 Auto-Titrator (Model -Metrohm-702 SM Titrino)
 Liquid Particle Counter (Model- Laser II)
 Air Sampler (Make-Millipore)
 HPLC (Make- Shimadzu LC-2010)
 Gas Chromatography with Head space (Make-Agilent)
 FTIR (Make- Perkin & Shimadzu) & FTNIR

4. PERSONAL DETAILS
Father’s Name : Mr. Bishnudeo Prasad
Date of Birth : 10-Jan-1982
Permanent Address : Village- Khaira, P.O.- Murgiyachuck, Dist- Nalanda
State-Bihar
Computer Literacy : Ms-Office and Basic knowledge of computer
Language Known : Hindi & English
Marital Status : Married
Ajay Kumar
(APPLICANT)
Date:
Place: