Curriculum-Vitae

Sujit Kumar G.Mishra

srms31@rediffmail.com Mobile # +91-9962207534, 8754455774

PERSONAL SUMMARY

A post graduate(M.Sc.) in Bio informatics and MBA in Operation and supply chain Management

(Eminent Institute) and having 20 + years of experience in the areas of Production(Lyophilization, Dry powder, large volume and small volume injectables and ophthalmic) Validation, Remediation, Plant commissioning, Scale-up & Technology transfer.

Fuelled with strong customer-centric approach on my endeavors, I have proven experience in excelling at business expectations.

Objective:

Looking forward to a very challenging career, which will help me in contributing my best for the organization as well as helping my desires to learn new technologies and think globally.

Personal Skills:

Leadership skills, comprehensive problem solving abilities, good verbal and written communication skills, ability to deal with people diplomatically, highly motivated to learn and gain new things, team facilitator, Fundamentals of continuous improvement.

Present Employment Experience

Joined as Senior Manager – Manufacturing Remediation in the Month of Nov-2014 .

Transferred to production as an overall block in-charge ( Penem facility) in the Month of Feb-2015 and promoted as DGM –Production, in April-2016

Currently working as Deputy General Manager (DGM) – Production, Hospira Healthcare India Pvt. Ltd, A Pfizer Company (Chennai, TN). Handling Overall activities of Penem block wherein Penem based sterile injectable are manufactured by Lyophilization and Dry powder filling.

Job Responsibilities:

Reporting to Head-Production.

In addition to technical responsibility, cultural change, motivation sessions for shop floor employees, contractors etc. to understand difference between mistakes and falsification.

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Planning and execution of manufacturing activities of block.

Coordinate for validation related activities

To take measures for optimum capacity utilization of plant.

To achieve standard yield and output and implement suggestions for cost reduction and improvement in productivity.

To initiate cost saving measures on basis of Raw material & Ex factory costing.

Prepare production reports and represent the department in the meetings.

Coordinate with other functions e.g. Warehouse, Q.A and Engineering to ensure smooth functioning of the block activities.

Costing: Identify areas and achieve MUV & OH recovery by cost optimization. Prepare Revenue, CAPEX, Yield & Manpower budget of block.

GMP: Review and Approval of SOP’s, BPR’s, BMR’s, validation protocols and reports. Perform Equipment qualification (URS, IQ, OQ, PQ), process validation &cleaning validation studies. Implement and follow Quality systems such as Change control, Deviations, CAPA, OOS, OOT, Market complaints etc. Prepare and approve TNI (Training needs identification) and JD (Job description) of team members. Conduct GMP and Functional trainings. Conduct internal audit of other departments. Perform validations as per VMP and review reports.

Validation: Exposure to validation activities related to Lyophilization, Liquid filling, Dry powder injectable, Steam sterilizer, Dry Heat sterilizer, Sterilizing Tunnel, Vial washing machine, Vial sealing machine, HVAC, SIP of equipment’s, Media fill, Air flow visualization (smoke study), Container cleaning validation, Container closure seal integrity, Compressed air and nitrogen system validation, Steam quality, Process validation, Cleaning validation, Equipment qualification etc.

Guidelines: Well versed with FDA, EU, ICH, WHO, ISO, PIC’s, guidelines and PDA technical reports

Regulatory Audits: Faced regulatory audits by USFDA, MHRA, TGA & WHO.

Safety: Implement company’s safety policy and ensure following of safety procedures and use of PPE’s. Conducting HAZOP & JSA studies. Reporting accidents, incidents and near miss incidents.

ETP: Initiate measures for conserving natural resources like energy, water, etc, if required initiate suitable modifications in plant/process/operations. To take measures for reducing water consumption .

HR: To conduct interviews for recruitment of manpower, manpower budgeting, optimum utilization of manpower by reducing overtime, training and induction of plant persons, conducting appraisal and target setting of team members, providing opportunities for manpower development.

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Summary of Experience

SR. NO.

ORGANIZATIONAnd LOCATION

DESIGNATION DEPARTMENT PERIOD

01 Hospira Health Care Pvt. Ltd, A Pfizer Company

Deputy General Manager

(DGM)

Dry powder and lyophilized injectable ( Small Volume Injectable)

1 April 2016 till date

Nov 2014 to till date

Senior Manager

Manufacturing RemediationNov 2014 to Mar

16

02

Baxter India Pvt. Ltd.

Aurangabad(Maharashtra)

Manager- production

FFS- Production(LVP)

May 2012 to Oct-2014

(Nov-2004 to Oct-2014)

10 years

Assistant manager production

FFS-Production(LVP)

Dec-2010 to Apr-2012

Team leader

(Sr. Executive) FFS-Production

(LVP)Apr-2005 to Dec-

2010

Production Officer

FFS-Production(LVP)

Nov-2004 to Mar-2005

03Bharat Serum &

vaccines Pvt. Ltd.,Ambernath,

Mumbai

Executive-Production

Small volume Injectable and Biological

InPlasma Proteins Division

Feb 1999 to Nov. 2004 05 years 10

Months

04Gan Pharma Pvt. Ltd. Kandiwali

Mumbai

Production Chemist

Small Volume Injectable, Ophthalmic and Dry powder

injectable

Dec-1996 to Jan-1999

03 years

Products Handled:

Dry Powder Injectables: Mero Penem, imi+cila-penem, Erta Penem, Ampicllin, Cloxacillin, Ceftriaxone sodium, Cefotaxime Sodium ,Large volume- Normal Saline,Gluscose, Ringer lactate,Blood product and Hormones: HMG,HCG,FSH, Monoclonal, Anti snake venom, Anaesthesia: Profol, Anti cancer:Cisplatin,Amphotericin.

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Educational Qualification:

MBA –Operation and supply chain with first class in 2015, from Eminent Institute of Management, affiliated to Vardha University

M.Sc. (Bioinformatics) from BAMU, Aurangabad in 2008.

B.Sc. (Chemistry) from Mumbai University, Mumbai in June 1992 with First class.

Professional Training and Certification:

Approved for Injectable manufacturing from FDA, Mumbai

Diploma in cGMP

Certified from Kanzen institute for Lean champions.

Green belt for operational excellence by Baxter incorporation, USA.

Certified as an Innovation coach

COMPUTER PROFICIENCY :

Microsoft Office, SAP, TrackWise, IsoTrain

Projects Handled (lead role):

In Hospira , A Pfizer company :

A) Completion of Ertapenem Facility Modification, area and equipment qualification, scale up batches.

B) Increased batch from 70 kg to 100 Kg: Lead and implement the capacity utilization for manufacturing line.

C) Aseptic Set up optimization and its qualification. D) Autoclave load optimization and its qualification.

In Baxter (I) Pvt Ltd:

A) Baxter Rise : - Lead from production for Baxter Rise Project which was one of the largest project launched By Baxter Corporation USA for setting up manufacturing facility in India for I.V. and PD Bags . Actively involved in Budgeting, finalization of equipment’s & its URS, Layout finalization for facility etc.

B) VIP : - Lead for Value Improvement Project from Production area which was launched by Baxter Asia-Pacific for controlling cost of product for all manufacturing facilities across Asia-Pacific region, Which was monitored & guided by Baxter Management Asia-Pacific headquartered at Singapore.

C) B4One :- Member for B4one team project which was launched by Baxter word-wide for implementation of Updated version of ERP system i.e. Updated Version of J.D. Edward Enterprise.

In Bharat Serums and Vaccines Ltd.

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A) Ambernath facility Setup : - Actively involved in Ambernath facility setup of Bharat Serum & Vaccines including Validation (IQ, OQ, PQ) for all equipment’s including Washing, Filling, Sealing &lyophilizes including all Packing equipment’s along with process scale up & its validation.

Machine handling :-

Having Deep Knowledge of following machines:-

HPHV Steam Sterilizer (Fedigree, Machine Fabric Lance Eng.),

IMA machines for Vial washing, filling, and capping.

Lyophilizer from HULL and Heto-holten

Vial Filling Machine (Petals India) & FFS machine (Rommeleg, Germany).

Tunnel (Techno Pack, Petals India),

Vial filling m/c (Petals India),

Capping and Sealing m/c (Balaji , Petals India, Bausch + Strobell)

Pam Pac Cartonator (CP120), Maharshi Labeling.

Adam made CIP and SIP Module,

Schoeller - Bleckmann Medizintechnik (Hot Shower Technology Sterilizers)

Interest and Activities:

I am always interested to learn new technologies, new concepts ,innovative works and for the development of new projects.

Date of Birth : 15 Sept. 1973

Marital Status : Married

Hobbies : Reading, Watching News & Music.

Place: : Chennai Date:

(SUJITKUMAR G. MISHRA)

Current Salary: 23.34 Lacs PA

Notice Period: 3 Months

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