Engineer Manufacturing
Resume:
* ***** **, *** # *, Somerset, NJ - *****
*****.********@*****.***
Chirag Ka.Patel
SUMMARY OF PROFESSIONAL QUALIFICATION AND SKILLS :
• Process & Cleaning Validations
• 21 CFR Parts 11, 210, 211, 820
• cGMP/GDP/GLP Regulations
• Risk Assessment Techniques- CAPAs, Root Cause Analysis, Change Control
• Statistical Software (MINITAB 15)
• Quality Management
• SOPs, SAP
• Internal audit and Vendor qualification
• ICH and USFDA guidelines and documentation systems
• Aseptic Manufacturing operations experience
• ISO 13485
RELATED EXPERIENCE:
PHARMACEUTICAL QUALITY SPECIALIST, US Pharma Lab, North Brunswick, NJ, USA
( APRIL 2011 to PRESENT )
• Participated in process and cleaning validation, verification activities including defect resolutions
• Maintained awareness of manufacturing activities by routine direct observation
• Mutual Accountability with VSO team to investigate, propose and initiate corrective and
preventive action (CAPA) for equipment and process related issues based on root cause
analysis
• Mutual Accountability to review and propose revisions to manufacturing batch records and
SOP’s as required
•Responsible for ensuring the quality of product being manufactured (IPQA) meets the required
parameters
•Responsible for ensuring that Standard Operating Procedures are consistently followed and that
cGMP’s are observed, in the course of incoming inspection, distribution, label control, destruction
and returns
• Lead and participate in site quality and process improvement initiatives
• Support, participate in and approve compliance – critical efforts including change controls
and validation processes related to value stream
• Handled tasks of reviewing supplier ratings for compliance within established limit
• Implemented and developed surveillance program and vendor performance reports
• Audit and assure internal quality system elements in manufacturing and operational
Support areas as per GLP and GMP under FDA regulated environment .
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3 Reler ln, Apl # L, Somerset, NJ - 08873
*****.********@*****.***
PHARMACEUTICAL ENGINEER, Baroque pharmaceuticals Pvt. Ltd, INDIA
(June 2009-december 2009)
• Handled the responsibilities of developing manufacturing processes of drug products
• Assigned the tasks of assisting senior engineer in the implementation of manufacturing process
• Performed the responsibilities of verifying the stages of drug production to ensure that it meets
quality standards
• Responsible for analyzing and troubleshooting manufacturing and drug manufacturing equipment
• Assigned the responsibilities of operating and maintaining equipment as well as performing
execution of test plans
• Handled the tasks of preparing technical reports and production rates and update the report to the
production head
• Performed the responsibilities of assisting manufacturing staff in researching and developing the
latest technologies
CURRICULUM PRACTICAL TRAINEE, Moxy Laboratories, Vadodara, INDIA
(May 2007- August 2007)
• Aseptic gowning • clean room behavior training
• Handling of syringes and vials • Sterilization and sanitization of equipments
• QC inspection of syringes and vials • Aseptic Room and line clearance
• Harvest/filling/sealing operations • Media/culture preparation and propagation
EDUCATION:
Master of Science in Pharmaceutical Engineering (January 2010 – May 2011)
New Jersey Institute of Technology, Newark, New Jersey, USA
Bachelor of Pharmacy (July 2005- May 2009)
Gujarat University, Ahmadabad, Gujarat, INDIA
REFERENCES:
Available upon request
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