1. KAMAL KUMAR
Email: kamal2704@gmail.com Phone: +91-8884667773
CAREER OBJECTIVE
To work in an organization that gives me a chance to update my knowledge, enhance my skills and to be a
member of a team that excels in working towards the growth of the organization.
STRENGTHS AND AREAS OF INTEREST
Quality Assurance activities and Documentation related to QA like Training, Auditing, Deviations, Change
control process, Annual Product Quality Reviews and In-Process activities etc.
PROFESSIONAL EXPERIENCE
A results oriented professionalwith oveall 4 years of work experience in Quality Assurance of Health care
products.
1. As Solution Architect (Technical Trainer): Strides Arcolab Limitd., Bangalore from February
2015 – Till Date.
Job Role: Administrator role in UL Compliancewire Learning management system
 Updation of training using UL Compliancewire (as a part of project) and Wisdon Web training tool.
 Witnessing activity of personal involved in operation of compression activity through electronic forms
using UL training tool.
 Develop and maintain robust training need identification Plan, coordinate and get involed in training and
qualification of personal which includes Job Role Mapping, Curriculum updation and assigining Training
accordingly.
 Execute technical induction programme for newly joined employees in cordination with department head
and HR.
 Upload training details in Learning Management System.
 Manage and archive training records of all departments.
 Verification of the documents received from various departments and for compliance to the current
formats and requirments.
2. As Executive (Quality Assurance): Biocon Pvt. Ltd., Bangalore from March 2012 – February 2015.
Job Role:
As a part in QMS
 Compilaton of Investigation data for deviations and Review of Change Control.
 Involved in preparation of Protocols, reports and execution of Process validation, cleaning validation and
cleaning verification. Preparation of Protocols, reports and execution of Shipping validation.
 Preparation and review of Annual Product Quality Reviews. Review of SOP’s.
 Review and compilation of data for Out of specifications and Out of trends.
 Handling of customer complaints and customer queries. Handling and filling of customer Questionnaires.

2. KAMAL KUMAR
Email: kamal2704@gmail.com Phone: +91-8884667773
As In-Process Personal
 Execution of routine cGMP rounds and Conducting and reporting internal audit
 Issue of Batch Manufacturing record and corrosponding Packaging and Dispatch Records. BMR review
and Approval for Batch Release. Dispatch inspection as per Packaging and Dispatch record. Verification
and Approval of finished product labels in SAP and ERP.
 Process monitering during API’s manufacturing. GMP regulations, and Quality Audits.
 Area and Equipment clearance at different steps during manufacturing process.
As a part of Trainer
 Prepare and conduct technical training programs. Including Assessing training and certification
requirements and Deploy training to targeted personnel.
 Prepare training material and classroom agenda and Conducting presentations
 Audits coordination in USFDA, KFDA, EUGMP and many customer audits.
CERTIFICATE OBTAINED
Certified for Internal Quality Auditor Trained by Quality Assurance Department, Biocon Limited.
ACADEMIC EXPERIENCE
PROJECT- “Process Validation of Extended release Bi-Layered Tablet containing Metformin,
Pioglitazone and Glimepiride”. BAL PHARMA LTD (UNIT-I) – Bangalore from April 2011 –
December 2011.
PRESENTATION AND PARTICIPATION
 Presented poster in 63rd Indian Pharmaceutical Congress-2011, Nov 16-18, 2011 (I.P.C) “Quality Risk
Management and Assessment (An Approach to Mitigate Risk in Pharmaceutical Industry)”at Bangalore.
 Participated in Indo-American Pharmaceutical Regulatory Symposium, Nov 20-21, 2010, “Comparison
Between India And Us Patents” at Sri Ram Chandra University, Chennai.
 Participated in National Seminar on “eCTD Submission, Challenges and Future Perspectives” at Mysore,
Karnataka.
QUALIFICATION
 M. Pharmacy (Pharmaceutical Quality Assurance), 2012 - JSS College of Pharmacy, Mysore, Karnataka
(affiliated to JSS University, Mysore); Distinction with 78.92%.
 B. Pharmacy, 2009 - JSS College of Pharmacy, Mysore, Karnataka (affiliated to Rajiv Gandhi University
of Health Sciences); Aggregate First Class with 72.85%.
 D. Pharmacy 2006 - JSS College of Pharmacy, Mysore, Karnataka (Board of Examining
Authority, Bangalore); Aggregate First Class with 69.20%.