Laboratory and Pharmaceutical Quality Assurance Expert
RESUME_JP_new
1. JAGADMBAY PRASAD SINGH
(QUALITY PROFESSIONAL withmore than12 years of experience)
(M.Sc. in Organic Chemistry, PG Diploma in Applied Analytical Chemistry)
503, Block-A, Ravindra Apartment, Baltana,Mohali, Punjab
E-mail: fylfot_jp31@rediffmail.com
Mobile: 91-9779575121
Mission:
To be a complete Quality Professional by respecting all the regulatory and statutory guidelines and
integrate them for the betterment of business and well-being of patient.
Personal:
Age 37
Date of Birth: 12/05/1978
Father’s Name: Sh. KaroriLal
Nationality: Indian
Passport No. : K9028935
Married, two children
Good Health
Education:
M.Sc. (Organic Chemistry: Year2001 in first class
[from Vikram University Ujjain]
PG Diploma in Applied Analytical Chemistry:Year 2002 in first class
[from Himachal Pradesh University, Shimla]
B.Sc. (Chemistry): Year 1999 in Second class
[from Vikram University Ujjain]
Current Employment Detail:
Torrent Pharmaceutical Ltd.
Department : Quality Control
Designation : Asst. Manager
Current Salary : 7.2 Lac/Pa
2. Previous Employment:
Organization Designation Duration
Ind-swift Laboratories Ltd. Asst. Manager Jun.15 to Sep.15
Sun Pharmaceutical Industries Ltd. Executive Nov.08 to Jun.15
Cipla Ltd.(OSD formulation unit)
Section Head-FG &
Validation Section
Oct.04 to Oct.08
Torque Pharmaceuticals Analytical Chemist Aug.03 to Sep.04
Highlights of work life:
Working as a Quality professional in Pharmaceutical industry in India for last 12 years.
Section in-charge of finished product section.
Planning, execution and releasing of finished products.
Experience in hosting certification audits of regulatory agencies and customer audits.
Experience for development, implementation and improvement of Quality Management System.
Facilities and critical systems validation in Pharmaceutical facility including IQ, OQ and PQ of
equipment.
Responsible for preparation and review of Plan, Protocol and Procedure of various activities.
Handled wide range of product like Tablets, Capsules, sachet etc.
Prepare standard operating procedure related to quality control department, simple and
elaborative.
Prepared and implement system configuration, user configuration and backup guideline for
computer system associated with laboratory instruments.
Validate spread sheet at plant for increase the productivity in quality control laboratory.
Quality Management System:
Preparation and review of qualification / Validation documents of QC instruments.
Change control, Deviation, internal audits and training management.
Participate in investigation, RCA and CAPA etc.
Initiating change control, OOS investigation activity and initiation of deviation activity in
trackwise software.
Documentation as per regulatory guidelines.
Quality control instruments and systems:
Calibration and Preventive maintenance of different laboratory instrument/equipment.
3. Qualification of equipment.
Backup and restorationof application software.
Laboratory Control System:
Modern Laboratory Management System as per 21 CFR 58,210 and 211.
Oversees analysis of various RM, In process and finished dosage forms as per USP, BP, EP,
JP, IH and provide direction to achieve target.
Follow up with external parties and contract analysis labs.
Determines QC department resource needs.
Maintain and archive analytical records, reports and maintain data accuracy.
Review of Specification, STP, SOPs, GP and protocols.
Initiating change control activities for SOP, specification and STP in DCM software.
Participate in internal and external audits.
Review of technology transfer / method transfer as regulatory requirements.
Oversees management of reagents and standards like reference standards, working standards
and impurity standards used in analysis.
Achievements:
Approval of regulatory inspections In Ranbaxy Labs Ltd, Mohali: USFDA, ANVISA-Brazil, WHO-
Geneva, Canada Health, EU-Germany, NMA-Romania, MCC- South Africa, PMDA -Japan and
TGA-Australia.
Successfully implement and monitored Documentum Compliance Management (DCM) and
Learning Management System (LMS) in Ranbaxy Labs Ltd.
Enhance and developed in house testing capability and reduce outside testing.
Instruments Handled:
Sophisticated analytical instruments like:
HPLC (Shimadzu, Agilent, Waters), UV-Vis Spectrophotometer, FTIR, Coulometer, Karl Fisher,
Autotitrator, Dissolution Tester, Malvern Master seizer, Alpine Air Jet.
Strength:
Understanding of various guidelines like: cGMP, FDA, WHO & ICH.
Maintain current job knowledge and skills
Operation, maintenance and trouble shooting of different QC instrument.
Hobbies:
Listening music, playing and watching games, movies.
Signature
Jagadmbay Prasad Singh