SYNOPSIS

Dynamic, result oriented Professional with more than Five years ‘experience in Process Development, Technology transfer, Production & commissioning. Ability to deliver and execute on well rounded decisions that drive achievement of “big-picture” business objectives and quality objectives of Company.

Adept at working in high pressure environments with strict deadlines and multiple deliverables.

Team Player with strong problem solving skills.

Excellent decision making skills with a positive approach.

Strong communication and interpersonal skills.

CAREER PROFILE

Company Name

Year

Department

Reporting

Total year

Plethico Pharmaceutical

2010-11

Formulation development

(Apprentice)

Sr.Manager

Six month

Lupin Limited Indore

2011-2015

Process development & Technology transfer

Deputy General Manager

4.2

GSPL PUNE

2015-16

Process Technology

Sr. Manager

1.0

SKILLS

Process development

Process technology

Technology transfer

Process Expert on Wurster coater, HSMG, Coater machine.

Troubleshooting of Wurster coater, HSMG, Coater machine and all Compression machine.

Handling of Compression machine Fette, Killian, Sejong Korsch, Cadmach.

Software handling Novotek, SABA, SAP, Minitab, Change control management, Six Sigma study.

1 month training has been completed in GSPL Germany.

WORK HISTORY

GSPL PUNE(Process Technology)

2015-16

Key derivable :

Perform Process improvement, Process design/re-design and Process management.

Perform process design at lab scale and then transfer to commercial scale.

Focuses on developing & delivering near perfect product & services.

Reduces variation in process, measure of our process quality and continuous improvement for any condition for pharma formulation.

QbD based optimization of process by following DOE designs to ensure robust manufacturing process before transfer to site.

Preparation on technology transfer strategy with timelines, gap analysis, technology dossier and execution plan.

Proposing the batch size i.e. of the Demo, Exhibit & Commercial batches in view of equipment availability / capacity at the manufacturing location.

Trouble shooting activities during the exhibit batches and commercial batches at the manufacturing locations.

Work closely with project managers, sourcing team, business team and other formulation managers & extend help in delivery of projects on time

Project executed :

1.Mylan Laboratory Nashik

Project Title : 6 Glaat Wurster, One ton coater.

Role : Process Optimization and troubleshooting of 10 product on Wurster coater and Coater machine.

2.Zydus Laboratory Ahmedabad

Project Title : 12 Glaat Wurster, Coater, HSG Granulator.

Role : Process Optimization and troubleshooting of 5 product on Wurster coater, Coater machine and HSG Granulator.

3.Lupin Limited Goa

Project Title : Top spray, Wurster Coater, Coater,Dryer.

Role : Process Optimization and troubleshooting of 2 product on Wurster coater, Coater machine and Dryer.

4.Watson Limited Goa

Project Title : Top spray, Wurster Coater, Dryer, HSG Granulator

Role : Process Optimization and troubleshooting of 2 product on Wurster coater, Coater machine,HSG Granulator and Dryer.

5.Dr Reddy Laboratory

Project Title : Top spray, Wurster Coater, Dryer, HSG Granulator

Role : Process Optimization and troubleshooting of 2 product on Wurster coater, Coater machine,HSG Granulator and Dryer.

Lupin Limited(Process Development)

2011-15

Key derivable :

Execution of Scale-up, Exhibit, Process Optimization and Validation batches.

Facilitate the Technology transfer, Review of Master Batch Manufacturing Records.

Preparation and Review of Test batch Monitoring protocols and Process Validation protocols.

Preparation of Placebo batches for Q.C analysis

Reviewing the technical information sheet & product development documents received from F & D dept.

Preparing technology transfer dossier documents viz (MFC, MPC, Stability protocol & Sampling protocols) for the manufacturing & loan licensing locations.

Compilation of Test batch/Process validation Reports along with review of Executed BMR/BPR.

Preparation of Sampling plan for prescale-up/scale-up batches and review of scale-up reports.

Preparation and review of Commercial/Lab Note Book batch Stability protocols and Annexure’s to Exhibit batch protocols.

Management of all process development documents and Lab Note Book.

Initiation of request for SAP input data (BOM/Recipe) for exhibit and commercial batches.

Coordination with R&D, Manufacturing and PPC for timely availability of all RM and PM

Required for scale-up and Exhibit batches.

Active involvement in cost reduction projects.

Arrangement and Adequate availability of all relevant documents to QC,QA,RA leading to Technology transfer, regulatory filing and Product launch.

Initiation of request for SAP input data (BOM/Recipe) for exhibit and commercial batches.

Coordination with R&D, Manufacturing and PPC for timely availability of all RM and PM

Active involvement in cost reduction projects.

Arrangement and Adequate availability of all relevant documents to QC,QA,RA leading to Technology transfer, regulatory filing and Product launch.

ANDA Projects and Site Transfer projects :

Review of master manufacturing formula and sampling plan in necessary co-ordination with FRD.

Preparation of Bill of material for batch reference to Master manufacturing formula.

LNB issuance, maintenance and its review for pre scaleup batch.

Review of BMR, BPR, Sampling protocol and stability protocol for Scleup and Exhibit batches

Compilation of Summary report.

Preparation of Technology transfer documents for proper execution of batches.

Execution of batches on coordination with production and other departments and troubleshooting.

ACADMIC HIGHLIGHTS :

2011 Master of Pharmacy – Pharmaceutics(NDDS) from Oiental College of, Pharmacy, Bhopal (RGPV University) Secured 74.00 %

UNIVERSITY-Rajiv Gandhi Proudyogiki Vishwavidyalaya. Bhopal. (M. P.)

2009 Bachelor of Pharmacy from Rewa College of Pharmacy(RGPV) Secured 74.13%

UNIVERSITY-Rajiv Gandhi Proudyogiki Vishwavidyalaya. Bhopal. (M. P.)

2003 Higher Secondary Certificate (XII Std.) from Saraswati Higher Secondary School, Rewa, M.P. Board. Secured 75.20% (PCM)

2001 Secondary Certificate (X Std.) from Saraswati High school, Rewa, M.P. Board. Secured 72.20%

PERSONAL DOSSIER :

Father’s Name Mr. Ramchait Sohgaura

Mother’s Name Mrs. Suneeta Sohgaua

Date of Birth 15.01.1986

Sex Male

Nationality Indian

Marital Status Single

Mobile No 090********

Permanent address 5/632, Santoshi mata mandir marg, Dhekha,

District:- Rewa (M. P.) 486001

Place: - Pune Amit Sohgaura

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