Medical Device Project Management

RUCHIT DOSHI

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Woonsocket, RI-02895

Cell: 401-***-****

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OBJECTIVE: To excel as a professional in Pharmaceutical or Biotech or Medical Device Industry.

EDUCATION: Stevens Institute of Technology, Hoboken, NJ May 2010 Master of Science in Pharmaceutical Manufacturing Engineering

Graduate Certification, Stevens Institute of Technology

Validation and Regulatory Affairs

GPA: 3.87

Major Subjects:

Bioprocess Technology in Pharmaceutical Manufacturing, Introduction to Pharmaceutical Manufacturing, Introduction to Project Management, Validation and Regulatory Affairs in Pharmaceutical Manufacturing, Pharmaceutical Finishing and Packaging Systems–Solid Dosage, Regulatory in Pharmaceutical Industry, Contemporary Concepts In Validation, Quality in Pharmaceutical Industry, Designing of GMP Facilities.

Rajiv Gandhi University of Health Science, Bangalore, India December 2007

Bachelor of Pharmacy

Result: Distinction.

Professional Diploma in Clinical Research, India June 2006

Result: First Class

SKILLS: Lab Skills: Titration, chromatography techniques, granulation, disintegration,

Tablet, manufacturing and coating, preparing chemicals, TOC analysis, HPLC, Spectroscopy,

Writing and Intellectual Skills: Writing SOPs and Protocols, Maintaining Lab notebooks, Written

Research Papers on Validation, CAPA, Facility design, Granulation, Project Management,

Regulatory overview.

Software: MS Office, MS Project 2002, Statgraphics, Visio, Minitab, File Maker Pro

Communication: Above 100 TOEFL score, given many seminars on Pharma subjects, won prizes in

Debates and state level elocution competitions.

Regulatory: FDA, DEA, ICH, EMA, OSHA, Six Sigma Quality attributes, Medical Device regulations

Process Analytical Technology (PAT), Statistical Process Control, QSR regulations, educational

knowledge of regulations of Australia, Japan and India.

Process Knowledge: Upstream/Downstream manufacturing, OSD, Liquid /Parenteral.

WORK Tedor Pharma , RI July 2010 -Present

EXPERIENCE: QA Associate

• QA Review: Performing review of Master and Executed Batch Records for Compliance. Reviewing SOPs, Protocols, Raw Material and Finished Product Release, Deviation Reports, OOS, Sampling and Testing Protocol, Calibration results, Qualification reports and executed Protocols, Biennial SOP review.

• Writing: Creating and revising SOPs, Batch Records and Protocols, Deviation Report with CAPA, Change Controls, Official Forms.

• Report Compilation: Trending Reports with Statistical Representation, Annual Product Review, Qualification and Calibration Report, Process Validation Reports.

• Regulatory: Annual Report and CMC change reporting, Label revision, Assisting Regulatory Department for ANDA filing.

• Documentation: Maintaining Equipment files, Database entry and Filing, Archiving reports, Updating SOP index and circulating Satellite copies to individual departments.

• Equipment: Maintaining equipment database, Calibration Coordination, In-house calibration and qualification, temperature mapping studies and reports, issuing equipment ID numbers, maintaining equipment manuals.

• Miscellaneous QA activities: Product Release, Stability Coordination, Environmental Monitoring, Room Clearance, Environmental Chamber Maintenance, Receiving Raw Materials, DEA receiving of controlled substances, Training SOPs Circulation, Batch Record Issuance, Label review and label issuance.

• Project Management: Hands on experience on handling multiple project at one time, Scheduling and prioritizing tasks, planning considering worst case scenarios and slack time, resource allocution, follow up communication, compiling meeting minutes.

• Audit: Participated in internal audit and FDA audit. Answered and address the questions during the Audit.

Core Pharma, NJ July 2009-December2009

QA Validation

• Performed key role in Process Validation. Writing Protocols, Executing Protocols, Developing Statistical Report, Writing SOPs.

• Reviewing Documents, Annual Product Report, Internal Audits, Root Cause Investigation, SPC tools.

• Performed key role in Validation of Packaging line, purified water system, CAPA non-conformance

Team, MER reporting, Deviation Management, Cleaning Validation swab sampling

Stevens Institute of Technology, Hoboken, NJ May 2009- May 2010

Research Student, Teaching Assistant

• Performing research in Cleaning Validation on Cleanability, TOC, Bench scale apparatus

for developing cleaning procedure, Develop a Process Development and Validation program for

chocolate chips cookie manufacturing which is similar to tablet manufacturing.

Tuton Pharmaceuticals, Ahmadabad, India December2007- September 2008

QC lab/Audit

• Performed various assay and raw material testing in Wet chemistry, HPLC CU assays in HPLC lab,

Performed handling of CFAs (Certificate of analysis) in QC audit office.

ACTIVITIES: International Society of Pharmaceutical Engineering (ISPE), Catalyst Clinical, KLE group of society

Services, Global spec, Stevens Research Group.

HOBBIES: Sports, Music, Traveling, Public speaking.

REFERENCES AVAILABLE ON REQUEST

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