Quality Control Process
Resume:
* ***** **, *** # *, Somerset, NJ *****
****@****.***
Chi rag Ka. Patel
OBJECT IVE:
Thoroughly knowledgeable about all the branches of the pharmaceutical industry,
i ncluding drugs, medical equipment and health care services, I am looking for a position
w here I can contribute in providing better medical facilities to the community.
EDUCAT ION:
Master of Science in P harmaceutical Engineering (January 2010 – May 2011)
New Jersey Institute of Technology, Newark, New Jersey, USA
Bachelor of P harmacy (July 2005- May 2009)
Gujarat University, Ahmadabad, Gujarat, I ND IA
RE LATED EXPER IENCE:
Q UAL I TY ASSUARANCE SUPERV ISOR, US Pharma Lab, North Brunswick, New
Jersey, USA
( January 2012 to present )
• Participated in process validation activities
• M aintained awareness of manufacturing activities by routine direct observation
• Monitored “ visual Factory “ for quality performance
• M utual Accountability with VSO team to investigate, propose and initiate
corrective and
p reventive action (CAPA) for equipment and process related issues based on root
cause
analysis
• M utual Accountability to review and propose revisions to manufacturing batch
records and
SOP’s as required
3 Reler ln, Apt # L, Somerset, NJ 08873
****@****.***
• Performed product release / rejection function for in-process, bulk finished product
materials and in process packaged product
• Review and approve CAPA effectiveness evaluation based on quantitative and
qualitative
measurements
• W rite, revise and approve SOPs as necessary
• Lead and participate in site quality and process improvement ini tiatives and
p roject team
• Support, participate in and approve compliance – critical efforts including change
controls
and validation processes related to value stream
• Review and evaluate Quality Control results for raw materials, intermediates and
f inished
p roduct
• H andled tasks of reviewing supplier ratings for compliance within established
l imit
• I nstalled, maintained and revised operating plans, bar charts, cycles and work
sequences
• I mplemented and developed surveillance program and vendor performance reports
• Documented, developed and audited procedures and practices for QSR compliance
and
I SO 9001 certification .
• Developed and implemented systems for t rading production and performance
quality
levels
P HAR MACEUT ICAL ENG INEER, Baroque pharmaceuticals Pvt. L td, I ND IA
(June 2009-december 2009)
• Assisted in functions of tablet manufacturing such as weighing, mixing, blending
and granulation
• Performed the Quality Control Tests of tablet like disintegration, dissolution,
f riability, weight variation tests
• Performed filling and packaging of liquid dosage forms
3 Reler ln, Apt # L, Somerset, NJ 08873
****@****.***
• Supervised four member team of packaging line of tablets, capsules and liquid
dosages forms
• Analyzed in-process and final products using HPLC, GC, Dissolution and bench
Chemistry
• Experienced working in the GMP compliant environment and followed Standard
Operating procedures ( SOPs )
CURR ICULU M PRACT ICAL TRA INEE, Moxy Laboratories, Vadodara, I ND IA
(May 2007- August 2007)
• Performed QC tests using H PLC spectroscopy, redox, gravimetric and electro-
chemical ti t rations
• Prepared granules and cosmetics
• Performed Dissolution and Disintegration testing of tablets and capsules
• Worked very closely with product development staff and helped in establishment of new
method for product development using Knowledge of cGMP and ICH regulations
F I L L I NG AND FORM U LAT ION TECHN IC IAN, Moxy Laboratories, Vadodara,
I NDIA
( May 2007- August 2007)
• Aseptic gowning • clean room behavior t raining
• H andling of syringes and vials • A utoclave of tanks
• QC inspection of syringes and vials • Room and line clearance
I N TEREST:
Novel Drug Delivery Systems
REFERENCES:
Available upon request
Contact this candidate