Manager Training

BHUPENDRA PATEL

*** *, ****** ****, ***** OH• Phone: 419-***-**** • E-mail: *****************@*****.***

Professional Summary:

•Experienced in managing all aspects of personnel performance, staffing, training and discipline within the department as well as working with unionized work force

•Hands-on knowledge of manufacturing of tablets, capsules, oral liquid, vaccine and parenteral products, production planning and packaging

•Extensive experience in preparing and reviewing departmental Standard Operating Procedures, Master Batch Records and Validation Protocols

•Excellent knowledge about sterile products manufacturing, filtration, filling , inspection and clean room technology.

• Detail knowledge about CGMP and US FDA regulation.

•Proficient with computer software suites such as MS OFFICE, ERP and SAP

•Excellent time management, presentation, negotiation, problem solving and communication skills

•Demonstrated ability to effectively lead a team to achieve challenging production targets

Work Experience:

Production Manager

Sun Pharmaceuticals Industries Ltd. Bryan OH, USA 2011- Continue.

•Prepared and executed production plans for Oral liquid and Cream products.

•Completed investigation for material report and suggested CAPA.

•Reviewed Cleaning validation, process protocol and Master Batch Records.

•Reviewed and updated SOP’s for equipment and manufacturing processes.

•Maintained and control inventories for DEA materials.

•Prepared departmental budget .

•Staffing and recruited manufacturing personnel.

•Evaluated manufacturing and packaging process for man power requirement.

•Provided Technical support for trouble shooting on equipment and processes.

Manufacturing Facilitator- Sterile Operations 2008 – 2011

Merck & Co, West Point, PA, USA

•Supervised vaccine production and inspection department on daily basis

•Managed and motivated the team towards reaching objectives and initiate the proper action plan required to meet production and inspection targets

•Reviewed and updated standard operating procedures (SOPs) for vaccine products

•Reviewed batch records for accurate data entry

•Examined the logbooks for batch process entry and disinfection

•Reviewed and inspected the standard set for automatic inspection

•Performed operator’s annual qualifications and training for inspection- Online and Manual examine

•Hands-on operating knowledge of Brevetti Auto Inspection Machine

•Completed validation on auto inspection machine and inline inspection

•Completed media fill challenge test twice a year on all production lines successfully

•Attended monthly GMP walkthrough with GMP compliance team and prepared compliance report

•Generated deviation alert report and supported it for investigation

•Maintenance of reject cage for disposition of vaccine products

•Approved operator’s time cards and payroll on weekly basis

•Maintained GMP's standards for day to day activities

Senior Supervisor – Material Dispensing 2004 – 2008

Caraco Pharmaceuticals Ltd, Detroit, MI, USA

•Trained and supervised 6 junior supervisors and 42 operators

•Supervised the dispensing department for activities such as material dispensing, material tracking and reconciliation of materials

•Calculation 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

•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

•Execute Production planning and follow up with QC for material release as per the plan

Packaging Supervisor 2001 – 2004

Caraco Pharmaceuticals Ltd, Detroit, MI, USA

•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

•Verified all packaging materials are dispensed as per packaging work order

•Performed pre-operational checks for line clearance and in-process control on all packaging lines

•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

•Coordinated daily departmental activities and supported department manager to meet monthly targets

•Carried out performance management of team members to ensure that each line is staffed with qualified and motivated individuals

•Enforced all GMP’s, Safety and Environmental regulations as well as company policies

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

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