Raj Shekhar Singh

** ******** ********** ****, ********, NJ, 732-***-****

acdskb@r.postjobfree.com

Objective

To obtain a position that will take full advantage of my training and

acquired skills so as to positively influence company performance and

profitability.

Pharmaceutical Skills:

Strong knowledge and hands on experience of FDA regulations

such as 21 CFR Part 11.

Strong knowledge and hands on experience of (DQ, IQ, OQ,

PQ), as well as GxPs (GCP, GLP, GMP) guidelines.

Successful execution of several shutdown projects from

planning to execution.

Management of multiple capital projects from inception

through construction.

Preparation of capital expenditure, SOPs and maintenance

procedures.

Equipment Validated:

PK Blender (2,5,10,20,30, 60 Cu. Ft.), Gemco Blender (30,

60 Cu. Ft.), Fitz Mill, Roll Compactor, Sifter, Tray Dryer,

Hi-Shear Mixer, Manual Tablet Press (27, 35, 45 Station),

Hi-Speed Tablet Press, Capsule Machine, Capsule Polisher,

Deduster, Bottle Accumulation Table, Slat Counter, Tablet

Counter, Metal Detector Check Weigher, Cotton Machine,

Capper, Heat Induction Sealer.

Knowledge of the equipments used in the manufacturing and

packaging in the pharmaceutical industry.

Deviations, CAPA (Corrective Action and Preventive Action),

CRO (Change request order), PACAR (Problem Analysis and

Corrective Action Recommendation).

Knowledge of ERP System.

Computer Skills:

C, C++, Visual Basic, Pascal, Dbase, COBOL, FoxPro, MS Access, MS

Word, MS Excel, MS Outlook, Crystal Reports, MS Internet Explorer, Netscape

Navigator, Norton Utilities, MS Windows 98, MS Windows 95, MS Windows 3.11,

UNIX/LINUX, MS DOS, Windows XP, Windows NT/2000.

Experience

Supervisor Engineering (Maintenance and Validation)

Mirror Pharmaceuticals LLC, Fairfield NJ Feb 2011 till now

. Directs technical and administrative workers engaged in engineering

activities.

. Track calibration status of the equipments/instruments and inform

concern departments.

. Tracking and verifying preventive maintenance of manufacturing,

packaging equipment's and utilities.

. Responsible for equipment startup and training the operators.

. Documentation of the training to the operators and mechanics.

. Prepares the SOP for the preventive maintenance of manufacturing,

packaging equipment's and utilities.

. Responsible to maintain inventory of spares used in maintenance.

. Prepares the SOP for the operation of equipment used in manufacturing

and packaging of drug products.

. Follows the Safety Plan of the Company.

. Responsible for Safety and Security of the Company.

. Prepare IQ (Installation Qualification), OQ (Operational

Qualification) protocols.

. Execution of DQ/IQ/OQ.

. Track validation status of the equipments.

. Write CROs (Change Request Orders) to manage changes and deviations

within the manufacturing process.

. Manage capital projects from design through validation including

preparation of Capital Expenditure and contractor selection.

. Purchase the equipments and supplies required for the company.

. Prepare the purchase orders.

Facility Engineer (Validation Equipment & Facility)

Sun Pharmaceutical Industries, Inc, Cranbury, NJ April 2010 - Feb 2011

. PAI Readiness: Provides leadership /direction to assure Facility

Department is properly prepared and organized for FDA pre-approval

inspections (PAI) as well as general inspections.

. Investigation of failure of equipments and utilities and preparing the

Investigation Report.

. Preparing the monthly preventive maintenance schedule for the month.

. Prepare IQ/OQ protocols for the equipments used in manufacturing and

packaging of drug products

. Supervise the installation of new equipments.

. Supervise the validation of new and refurbished equipments

. Initiate and track Change Request for the Facility Department

. Assign the work order to the technicians.

. Complete the work order and get it approved.

. Responsible for commissioning equipments - documenting design

requirements and assumptions.

. Supervise the facility projects.

. Use ERP system for purchasing for the department.

Supervisor Engineering (Maintenance and Validation)

CorePharma LLC, Middlesex, NJ, USA Jan 2007 - April 2010

. Directs technical and administrative workers engaged in engineering

activities.

. Write CROs (Change Request Orders) to manage changes and deviations

within the manufacturing process.

. Initiate and track for the completion of PACAR and implement the

corrective actions.

. Track calibration status of the equipments/instruments and inform

concern departments.

. Prepare IQ/OQ protocols for the equipments used in manufacturing and

packaging of drug products

. Track validation status of the equipments.

. Issue work order to the technical workers.

. Manage capital projects from design through validation including

preparation of Capital Expenditure and contractor selection.

. Responsible for commissioning equipments - documenting design

requirements and assumptions.

. Supervise the validation of new and refurbished equipments.

. Responsible for equipment startup and training the operators.

. Prepare SOPs' for maintenance of equipments.

. Supervise the maintenance of equipment, utility and facility.

. Purchase the equipments, spare parts for the equipment.

Engineering Team Leader

CorePharma LLC, Middlesex, NJ, USA Oct 2006 - Dec 2006

. Preparation of IQ/OQ protocols for the instruments used in

manufacturing and packaging of drug products.

. Perform the IQ/OQ of the instruments used in manufacturing and

packaging of drug products.

. Preparing SOPs' for the equipments.

. Supervise & schedule the engineering team members.

. Documentation

. Assist the Plant Engineer in the expansion projects.

. Supervision of the new facility construction work.

. Co-ordinate in preparation of the facility validation protocol.

. Purchase the equipments and supplies required for the company.

. Prepare the purchase orders.

. Keep track of the purchase orders.

. Clear the invoices of the purchases and send it to accounts for

payments.

QA Coordinator

CorePharma LLC, Middlesex, NJ, USA April 2006 - Oct 2006

. Organized the schedule of drug preparation on receipt of the purchase

order.

. Managed the inventory of control drugs (Class-I,II,III).

. Managed the operation of vaults and cages where the controls drugs are

kept.

. Issue and track the 222 Forms.

. Reviewed manufacturing/packaging batch records of control drugs.

Manager

Quick Stop Food Store, Hillsborough, NJ, USA Aug 2005- Oct 2006

. Proved multi-tasking abilities by scheduling and supervising staff.

. Prepared and managed inventory.

. Prepared, managed and ordered for merchandise.

. Prepared the pay roll for the employees.

. Wrote a small Visual Basic Application to help facilitate inventory

management.

. Also, assured proper operation of store computers and other

equipments.

Sales and Service Manager

Raj Informatics, Satna MP, India Feb 2000-June 2005

Responsibilities included purchasing, merchandising, customer service, and

all facets of running a Computer Store.

. Deal with the customers regarding sales and service of Computer.

. Support the customers over the phone when they had problems regarding

the computer hardware and software.

. Build and test complete computer systems.

. Service customer equipment on site and in house.

. Provide training on equipment and software.

. Inside sales of supplies and equipment.

. Maintain supply and parts inventory.

. Manage daily office operations.

. Hired and trained staff.

. Managed and supervised the support staff.

Guest Faculty

Government P.G. College, Satna, MP, India May 2002-Sep 2004

. Taught MS Office, Computer Networks, Visual Basic, C, C++.

Help Desk Technician and Service Engineer

July 1998-Jan2000

Net Brains' Solutions, Goregaon (W), Mumbai, India

. Managed the Help Desk function as well as prioritized, resolved,

recognized end-user computer problems.

. Assembled new computers and installed software

. Networking of computers

Education

B.E. (Computer Science and Engineering) 1998

Shivaji University, Kolhapur, Maharashtra (India)

Personal:

Citizen of US

References:

Available on request.

Contact this candidate