BHUPENDRA PATEL
* ******** **, ***********, ** .Phone: 647-***-**** .E-mail:
*****************@*****.***
OBJECTIVE
To secure a supervisory position pertaining to manufacturing or packaging
utilizing my extensive in-depth knowledge and experience within the
pharmaceutical industry
CAREER SUMMARY
. 10 years of experience in pharmaceuticals manufacturing, packaging and
operations
. Achieved highest targets for Rotateq vaccine for year 2010 - 19.5
million dosages
. Exceeded targets by exceptionally raising Manufacturing department
RFT ratio to 93%
. Prepared and reviewed Standard Operating Procedures, Master Batch
Records and Validation Protocols
. Technical writing experience related to investigation reports, CAPA,
APR's etc.
. In-depth knowledge of USFDA, cGMP's and clean room technology
. Managed all aspects of personnel performance evaluation, staffing,
training and discipline within the department as well as working with
a unionized work force
. Proficient with computer software suites such as MS OFFICE, ERP and
SAP
Manufacturing Supervisor - Sterile Operations
. Supervised vaccine production and inspection department on daily basis
. Operating knowledge of Delta V and complex equipment
. Maintained sterile area and reviewed all logbooks for sanitization and
cleaning
. Performed pre-operational checks prior to sterile vaccine filling
. Monitored sterile vaccine filling, sterile equipment and thawing and
deactivation
. Reviewed batch records and associated documentation for accurate data
entry
. Completed media fill challenge test twice a year on all production
lines successfully
. Maintained all equipment and their calibration
. Reviewed and updated standard operating procedures (SOPs) for vaccine
products
. Hands-on operating knowledge of Brevetti Auto Inspection Machine
. Attended monthly GMP walkthrough and prepared compliance report
. Generated deviation alert report and supported it for investigation
. Approved operator's time cards and payroll on weekly basis
. Maintained GMP's standards for day to day activities and operators
training on new SOP's
Senior Supervisor - Material Dispensing
. Prepared daily and weekly schedule for dispensing activities for up to
42 staff
. Calculated of API for batch charge
. Monitored department for compliance of cGMP, US FDA, DEA as well as
handling and dispensing of control substances (Class IV,V)
. Reviewed batch record after completion of dispensing activities
. Prepared SOPs for dispensing and material handling
. Trained supervisors on departmental SOP's and ERP
. Investigated and completed incident report (QIR/QDR) and suggested
corrective action plans
. Attended scheduled meetings and devised action items to meet micro-
plans
. Prepared monthly statement of dispensing activity, stock
reconciliation and verification of inventory history report
. Executed production planning and follow up with QC and QA for material
release as per the plan
. Increased dispensing outputs by revising procedures
BHUPENDRA PATEL Page 2/2
Packaging Supervisor
. Supervised packaging line for tablets and capsules from filling to
final packing
. Trained total of 38 operators for packaging line operation and
related documentation
. Supervised operation of bottle dispensing machine, online tablet
counting/filling machine, online heat seal machine, and automatic
labelling machine
. Performed pre-operational checks for line clearance and in-process
control on all packaging lines
. Troubleshoot packaging equipment and provided operational support as
required
. Performed verification and review of packaging work orders, evaluation
and sign off for packaging line and equipment cleaning as required
. Performed accountability of printed packaging material i.e. labels,
circulars, etc.
. Prepared standard operating procedures (SOPs) for the packaging
department
. Investigated and completed NCRs, incident report (QIR/QDR) and
suggested corrective action plans
. Attended scheduled production meetings and devised action plan meet
monthly targets
. Enforced all GMP's, Safety and Environmental regulations as well as
company policies
WORK EXPERIENCE
Manufacturing Facilitator- Sterile Operations
2008 - 2011
Merck & Co, West Point, PA, USA
Senior Supervisor - Material Dispensing
2004 - 2008
Caraco Pharmaceuticals Ltd, Detroit, MI, USA
Packaging Supervisor
2001 - 2004
Caraco Pharmaceuticals Ltd, Detroit, MI, USA
TRAINING
. In-house yellow belt six sigma training
. In-house clean room technology training
. First line supervisor training for Process Improvement
EDUCATION
Bachelors of Science - Chemistry
Gujarat University, India
REFERENCES
Available upon request.