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Quality Control Process

Location:
Hatfield, PA, 19440
Posted:
March 15, 2013

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Resume:

* ***** **, *** # *, Somerset, NJ *****

609-***-****

abopl0@r.postjobfree.com

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

609-***-****

abopl0@r.postjobfree.com

• 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

609-***-****

abopl0@r.postjobfree.com

• 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



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