Pushpendra Singh

***/*,*** ***** ******,

Teachers colony, Chandapura,

Bangalore. India

Mob:91-888*******

91-974******* Email: adh72o@r.postjobfree.com

Seeking a position to utilize my skills and abilities in pharmacy field that offers professional growth while being resourceful, innovative and flexible.

Area of Strengths (Manufacturing)

Technical Knowledge

Handling of QMS in trackwise.

Trouble shoot for varied items manufactured.

Compression, Encapsulation & Coating in-charge.

Internal Auditor.

SME (Subject matter expert)during Audit.

Conduct trainings.

Handling of Document management system in Live link software.

Well versed with FDA guidelines and QA systems.

Lean practicner (Green Belt in Lean Six Sigma)

Exposure to various international audits like USFDA,MHRA (UK),

TPD(HEALTH CANADA)MCC(SA),ANVISA(Brazil),TGA,GCC,TURKEY.

Soft Skills

Flexibility- able to quickly adapt to changing situations.

Quick learner.

Discipline oriented.

Carer Profile-12 years 04 month’s experience in Production/Quality Management System (QMS)

APOTEX RESEARCH PVT LTD. Bangalore,India, A MHRA, TPD,TGA,Certified Canadian MNC.

Sr. Pharmacist -production (Section In-charge)From July 2012 to Present

AUROBINDO PHARMA LTD., Hyderabad, Andhra Pradesh, India, AUSFDA, MHRA, TGA,TPD Certified Company.

Executive- Production,Oct-2010 to June-2012.

GLENMARK GENERICS LTD. Goa, India, A USFDA, MHRA, ANVISA, TPD, MCC, GCC Certified Company.

Officer-Production, Dec.2009 to Oct 2010.

ENCORE HEALTHCARE PVT. LTD., Aurangabad,Maharashtra, India, AWHO GMPCERTIFIED company engage in Loan Licence job work for GSK, Fulford, J&J, Aventis, Abbott, Umedica, Novartis, and P2P for Novartis.

Officer-Production, July2008. to Dec.2009.

Competencies

Apotex research pvt.ltd Bangalore.

Sr.Pharmacist – Manufacturing oral solids(Jul.2012 to till date )

Team Size-59

Responsibilities:

Working in Dosing Section as a in-charge & QMS (compression and encapsulation).

Production planning daily and monthly to achieve the targets.

Preparation of daily, monthly production reports.

Co-ordination with Purchase, Production, Q.C., Q.A.& PPIC to achieve the targets.

Ensuring the proper and effective manpower allocation to achieve the highest output.

Ensuring and execution of contingency plans as per committed dates schedule adherence.

Trouble shooting during the compression & Encapsulation of the various products.

Ensuring the quality systems during the manufacturing of the batch.

Working with the technology transfer department to validate the new products to complete the validation on different machines.

Ensuring the calibration of instruments in the area (Friabilator, D.T. Apparatus, Balances).

Ensuring the completion of preventive maintenance, AMC and calibration of machines and accessories as per their schedule.

Ensuring the GMP and cleanliness of the production area as per the regulatory standards.

Review of Batch Manufacturing Record.

Handling of compression tool room, indent of punches and dies and maintain all the tooling related documents.

Indent of change parts (Punches and Dies, dosing disc etc. )and vendor related indent.

Assessment of manufacturing documents in CCR trackwise.

Production approval of Batch manufacturing record in Document management system (Live link software).

To prepare and review SOPs related to various activities associated with manufacturing.

To conduct internal Audit.

Lean six sigma practicner for continuous improvement.

Initiation of Kaizen Activity.

Continuous improvement of Overall Equipment Effectiveness (OEE).

Coordination with new product launch department and technology transfer for new product launch and indent of compression, Encapsulation new tooling and spare parts within time limit.

Working with SAP PP system.

Handling of QMS ( Change control,Deviation,CAPA, Effective Ness check in track wise ).

Investigation, Root cause Analysis of any process/non process deviations during the routine production in track wise.

Working as a SME (subject matter expert) in Audit &Compliance.

To initiate the change control with respect to the proposed change related to system, facility, process and procedure in track wise.

Qualification of equipments.

Following machine handled

Korsch XL 400

Korsch XL 800

Gia MODULE S

Gia MODULE D

ZRO 90 T

LEGEND 1500

Palm glatt Coater.

Achievements

Audits faced like TGA,US-FDA,MHRA,TPD(HEATH CANADA)TURKEY, IGJ.

Successfully implemented the Reduction of change over process time of compression machine with the help of Lean concept (Kaizen).

Yield improvement project. (Kaizen).

Awarded for Lean work.

Aurobindo Pharma; Unit VII SEZ

Executive-Production(Oct. 2010 to Jun.2012)

Responsibilities:

Worked in production section (Compression, Encapsulation, Coating, Inspection, Thickness Sorting)

Ensured compliance to laid standards of the good manufacturing practices.

Complied with specifications and validated methods.

Prepared S.O.P, documents of Production in Tablet section.

Investigated any process deviation or non-compliance.

Complied with master documents.

Took preventive / corrective actions for observed non-conformance.

Exercised effective control over the environmental conditions in manufacturing.

Coordinated, calibrated and carried out preventive maintenance for all production equipment.

Carried out routine documentation as per regulatory requirements.

Ensure maintenance of production area to required regulations.

Maintained equipment to standards of cleanliness as regulated at all points of time.

Coordinated with production planning, manufacturing/packing departments.

Prepared monthly production report. Ensure that the standard yield of the products and packs are maintained and the production losses minimized.

Reconciliation of finished product.

Maintain Log Sheet.

Co-ordination with Purchase, Production, Q.C., Q.A.& PPIC to achieve the targets.

To initiate the change control with respect to the proposed change related to system, facility, process and procedure.

Implementation of CAPA.

Review of Batch Manufacturing Record.

To participate as a team member in audits compliance.

Worked with ERP system.

Following machine handled

Fette 3090 i 79 station.

Killian Synthesis 700(51, 63, 77& 85 Station.)

Gansons 66”

Gansons 60”

Thickness Sorter Machine.

Achievements

Successfully completed the audits like US-FDA(June 2012),TGA,KENYA,TURKEY with no critical/major/minor observations.

Higher Production achievements.

Glenmark Generics Ltd. Goa.

Officer-Production; December 2009 to Oct.2010

Responsibilities

Production Planning, equipments and area maintenance and trouble shooting on the shop floor.

Proper manpower handling, utilization and work allocation to the sub -ordinates

and operators.

Achieving of production targets with essential GMP’s and in-process quality checks as per BMR and SOP’s.

Ensure that the standard yield of the products and packs are maintained and the production losses minimized.

Reconciliation of finished product

Shop floor maintenance in manufacturing area of tablet.

Maintain Log Sheet.

Look out quality compliance.

Preparation of daily and weekly plan.

Co-ordination with Purchase, Production, Q.C., Q.A.& PPIC to achieve the targets

Review of Batch Manufacturing Record.

To participate as a team member in audits compliance.

Working with SAP PP system.

Achievements

Successfully completed the audits like TGA,MHRA(UK),MCC,GCC with no critical/major/minor observations.

Following machine handled

Sejong 37, 45, 49Stations (HRC & MRC).

Cadmach 37, 45, 55 Stations.

Encorehealth care pvt.ltd.Aurangabad(MH).

Officer-Production ;July2008. to Dec.2009.

Responsibilities

Achieved monthly production.

Daily manpower allocation and job allocation to technicians

Planned production as per availability of raw material to achieve plan.

Maintained inventory required for machines in production.

Reviewed and completed BMR’s and handover to next dept.

Reconciliation of finished product

Shop floor maintenance in manufacturing area of tablet.

Maintain Log Sheet.

Inter departmental Interactions

Priority of blend and finished samples to QC as per the requirement.

Involvement in the maintenance and procurement of the new and existing machines.

Providing the batches to packing as per the commitment dates for despatch.

Involvement with process development for executing exhibit and validation batches

Involvement with PDL for product related issues.

Involvement with QA related to change control, deviations and market complaints.

Qualifications

Qualification University Year

B.Pharm L.I.M.T.(University –UPTU) 2008

Green Belt Lean Six Sigma Anexas EU 2019

B.Sc KADC (Kanpur-University) 2003

HSC UP BOARD 2000

SSC UPBOARD 1998

Personal Information

Date of Birth: 13/05/1982

Languages: English, Hindi.

Marital Status: Married

Pushpendra Singh

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