Validation Specialist

Ravi Goswami

Apt *** D

*** ******* ******

Cliffwood, New Jersey 07721

Cell: 732-***-****

*********@*****.***

OBJECTIVE To seek challenging position in the Field of Ph armaceutical/ Biopharmaceutical industry

as Validation Specialist or Process Development Scientist or Quality Engineer or

Process Engineer that provides an opportunity for acquiring skills and deve loping

existing skills.

EDUCATION Stevens Institute of Technology, Hoboken, New Jersey

MS in Pharmaceutical Manufacturing, December 2014

• Main courses completed are Introduction to Pharmaceutical

Manufacturing, Validation and Regulatory Affairs in Pharmaceutical

Manufacturing, GMP in Pharmaceutical Facility design, and

Introduction to Project management, Engineering Economics & Cost

analysis, Regulation and compliance in the Pharmaceutical Industry,

Design and Management of Sterile Pharmaceutical Manufacturing and

Lean Six Sigma in Pharmaceutical Industry, Contemporary Concepts

in Pharmaceutical Validation

Shri B.M.Shah College of Pharmaceutical Education & Research, Modasa, Gujarat, India

Bachelor of Pharmacy, May 2009

High Honors

Department of Hospital Management, Patan, Gujarat, India

Mater in Hospital Management May 2013

High Honors

EXPERIENCE Pramukhswami Pharma Ltd, Santej, Gujarat, India

Assistant in Production Department 07/09 to 02/11

• Performed Quality Control Testing according to procedure.

• Find out risk and solve problem, Execute CAPA plan, Root cause analysis.

• Kept track of calibration of instrument at regular interval.

• In-process inspection of various tablet parameters like appearance, weight variation,

hardness, thickness, friability, disintegration and dissolution at compression stage.

• Check quality of product and improve process development steps.

• Reviewed and Audit document like Quality policy and approved Batch record, protocol

and generate reports.

Stevens Pharmaceutical Research Center Lab. Hoboken, NJ

09/13 – 12/14

Validation Specialist

• Develop and Review SOPs, VMP, Master Batch Record, Lab reports and Risk analysis

documents.

• Authored and Executed IQ, OQ and PQ protocols for manufacturing equipment’s.

• Process Validation protocol and documentation of each report including deviations.

• Validated different equipment like Autoclave, Oven, and Mixer.

• Prepared and maintained logbook according to GMP standards.

• Temperature mapping of an Oven using Omega Data Logger.

• Developed and Validate Swab sampling method using TOC analyzer for cleaning

validation.

• Performed Statistical Process Control (SPC) and quality tools like DoE (Design of

Experiment), Process Capability, ANNOVA, t-test, Accuracy and Precision, Process

control plan, change control, Gage Bias linearity study and Gage R&R using

Minitab17 statistical software.

Stevens Institute of Technology

Classroom Management Assistant 07/14 to 12/14

• Classroom Scheduling as per the Course Requirements.

• Generating reports using Excel.

• Updating Student records in SIS (Student Information System).

PROJECTS A project report on Hospital visit at Columbia Asia Hospital, Bengaluru, India

Spring 2011

• Visited five different multi speciality hospitals and prepared detail report

based on facilities available in individual hospital.

Six Sigma project on outpatient billing cancellation and refund at Apollo Hospital

International Ltd, Gandhinagar, Gujarat, India

Summer 2012

• Surveyed all out patients department in Apollo Hospital

• Find out details for outpatient billing cancellation and refund.

• Prepared a detailed Six Sigma project regarding it and hand over to Apollo Hospital

RSBY satisfaction survey at Civil Hospital, Visnagar, Gujarat, India

Spring 2013

• Surveyed for RSBY scheme satisfaction in patients

• Surveyed for RSBY scheme satisfaction in hospital staff

• Basic Life Support (BLS) training by American Heart Association

ACTIVITIES

(AHA) at 108 GVK- MRI at Ahmedabad.

• Participated and Coordinated in disaster mock drill at Medical College, Dharpur, Gujarat.

SKILLS Software: Microsoft Word, PowerPoint, Project

Minitab (Statistical tool)

“M- files” (Electronic Documentation)

Databases: Microsoft Excel

Operating Systems: Windows NT/9x/2000/XP/Vista/7/8

Lab Equipment Skills:

HPLC, Chromatography

Dissolution

Disintegration

Calibration, Validation, Installation and Qualification of Equipments

References Available Upon Request

Contact this candidate