1. RAM NARAYAN VISHWAKARMA Mobile No: +919913915660
8, Bhogipur, Tehsil: Ghanghata
+919375204768
Santkabir Nagar (UP) ram06215@gmail.com
OBJECTIVE:
To work in growing organization that utilizes and enhances my skills & experiences, such that I can
contribute my best to the growth of company as well as mine.
WORK EXEPERIENCE:
Having total work experience of 5 years in:
October 2014 to till Date : At present I am working in Amneal Life Sciences as
Executive in Quality Assurance. It is a US based company
having only US and Europe Market.
April 2013 to July 2014 : At present I am working in Cure Life Care Pvt. Ltd as
Executive in Quality Assurance. It is third party products
manufacturing company in India. Cure Life Care Pvt. Ltd.
is having three manufacturing line with BFS Technology.
June 2010 to March 2013 : Akums Drugs & Pharmaceutical Ltd. Plant-III in
Quality Assurance Validation. This Organization is
involved in the Production of Injectable Preparations
(SVP, LVP, Dry Powder & FFS). M/s Akums Drugs &
Pharmaceuticals Ltd. is ANVISA approved. Akums Drugs
& Pharmaceuticals Ltd. is one of the largest Third Party
LLM Company.
EDUCATIONAL QUALIFICATION:
B. Pharm. (2010) from S.G.I.T. Uttar Pradesh Technical University with 73.3% marks.
Intermediate (2005) C.B.S.E Board, with 65.4% marks.
High School (2003) C.B.S.E Board, with 75.0% marks.
Job Responsibilities at Amneal Life Sciences.
1. Preparation of IQ, OQ, PQ, RQ, CQ Protocols of Equipments and utility.
2. Reviewing of URS, DQ, IQ, OQ, PQ & RQ Documents.
3. Preparation of SOP.
4. Providing Training related to cGMP and Qualification.
5. Preparation of Project Validation Plan and follow-up and action plan related to qualification
activity.
2. 6. Review of vendor document and follow-up related to qualification documents.
7. Preparation of utility qualification protocol.
8. Co-ordination with Production, QC, Engineering and vendor for execution of Validation activity.
9. Review of instrument calibration certificates.
10. Preparation of Protocol and Execution of Temperature mapping activity of Ultra Low Freezer and
Walk-In cooling chamber.
Job Responsibilities at Cure Life Care Pvt. Ltd.
1. Preparation of validation Protocols.
2. Preparation of Water System validation Protocol.
3. Execution of all validation activities.
a) Validation of autoclave/ Moist heat sterilizer
b) HVAC Validation
c) Validation of Dry Heat sterilizer
d) Validation of Incubators(Walk-In Type)
e) Media Simulation studies for formulation (Liquid)
f) FFS Machine Validation
g) Super Heated Water Spray Sterilizer Validation
h) Compressed Air System.
i) Pharma Refrigerator Validation.
j) Multi Column Distillation Plant.
4. Preparation of Standard Operating Procedure (SOPs).
5. Preparation of Site Master File & Validation Master Plan.
6. Handle all the activities during Project Stage of the Plant.
7. Supervision of Installation activity in the Plant.
8. Clean Area Validation.
9. Implementation of GMP System.
10. Co-ordination with other department (Production, QC and Engineering) for execution of
Validation activity.
11. Implementation of Quality Management System.
12. QA System Development and Implementation.
3. Job Responsibilities at Akums Drugs & Pharmaceuticals Ltd.
1. Preparation of Validation Protocols.
2. Execution of all validation activities.
a) Validation of autoclave/ Moist heat sterilizer
b) HVAC Validation
c) Validation of Dry Heat sterilizer
d) Validation of Incubators(Walk-In Type)
e) Media Simulation studies for formulation (Dry powder/Liquid)
f) Sterilization-In-Place module Validation
g) Cleaning-In-Place Validation
h) Sterilization & Depyrogenating Tunnel Validation
i) Dry powder Filling & Sealing Machine
j) Liquid Injection Filling & Sealing Machine
k) Vial/Ampoule Washing machine
l) FFS Machine Validation
m) Validation of Walk in Stability Chamber
n) Compressed Air System & Nitrogen Gas Validation.
o) Pharma Refrigerator Validation.
p) Process Validation
3. Arrangement & showing of all the related Documents for Party & Regulatory Audit.
4. IPQA Activity.
5. Preparation Annual Product Review.
6. Co-ordination with other departments for Internal Audits.
INSTRUMENT HANDLED:
Air Borne Particle Counter
Aerosol Photometer
Digital Anemometer
Lux Meter
AUDITS FACED:
“ANVISA” Regulatory of Brazil in Year 2011 in Akums Drugs & Pharmaceuticals.
4. “WHO” in Year 2012.
“Ukraine” in 2012.
Party Audits
AWARDS & ACHIEVEMENT:
Employee of the Year 2013 in Cure Life care Pvt. Ltd.
COMPUTER PROFICIENCY:
• Microsoft office.
• Internet Applications
• Having good proficiency of Computer System (MS Office, Word, Excel, Power Point)
• Having good typing speed.
PERSONAL DETAILS:
Father’s name : Chandra Bhan Vishwakarma
Date of Birth : 6th
July 1989
Marital Status : Married
Nationality : Indian
Gender : Male
Language known : English & Hindi
PERMANENT ADDRESS:
Village-Bhogipur,
Tehsil-Ghanghata
District-Sant Kabir Nagar
U.P. (272172)
INDIA
DECLARATION:
I declare that all the above information given by me is genuine with my knowledge & belief.
Date: 17-May-15 (Ram Narayan Vishwakarma)
Place: Ahmedabad (Gujarat, India)