Quality Assurance Professional Experience

Krupal Patel

R&D Professional

MS Industrial Pharmacy, HPLC Certified

Parlin NJ, 08859 Email: ac0hlt@r.postjobfree.com Phone: 732-***-****

Profile Summary

Experienced Quality Assurance Professional with Formulation Development & Quality Compliance

Proven track record of excellent Research and Development skills

Hands on Experience of developing, managing and maintaining USFDA approved plant with GMP, GCP and other regularity guideline

Competent with MS Office, MS Visio, MS, and Métis® ERP

Area of Expertise

Formulation development (Qbd,QTPP)

Validation (Process and Cleaning)

Instrument Qualification (IQ,OQ and PQ)

Machine operation and troubleshooting

Regulatory Guideline(GMP,21 CFR)

Quality Management System

Quality Compliance

Analytical Techniques

GMP Documents Review and Approval

MS Office, MS Project, MS Visio, SAP® ERP

Professional Experience

Sun Pharmaceuticals, India Nov-2013 to Sep-2015

Quality Assurance Officer (Solid Oral Dosage form & Aerosol)

Prepared and examined Master Formula Record (MFR) and Annual Product Quality Report (APR).Calibration record and Validation Master Plan.

Conducted Internal Quality Audit and give quality observation against data integrity and GMP violence.

Reviewed and approved GMP documents (MBMR, BMR, SOP, BPR, Validation protocol and report).

Qualification of equipments (IQ, OQ, PQ) and review machine breakdown memo.

Critical Process Parameter (CPP) and Critical Quality Attributes (CQA) consider under documents review.

Performed in Process Quality Control (IPQC) by troubleshooting critical, major and minor problems using OOS, Change Control and Deviation.

Troubleshooting and preparation of Corrective and Preventative action (CAPA) plans.

Electronics transition of Batch release by considering COA of product via ERP and Metis online System.

Line clearance and assure to maintain GMP environment throughout product manufacturing and packing department.

Centurion Lab & Remedies, India May-2010 to May-2011

Quality Control Officer

Physical and chemical analysis of in process materials and finished product.

Analysis conduct on lab equipment like UV, HPLC, Dissolution Apparatus and Karl-Fischer analysis.

Maintained and reviewed QC lab documents and lab notebook.

Generate electronics COA from lab analysis data.

ACEDEMIC PROJECT

Gujarat Technological University

A research project and thesis writing on method development and validation of Olmesartan medoxil and Amlodipine Besylate by simultaneous estimation method on Bulk and Ph’Dosage form using HPLC which was linear, precise, accurate and robust than other method available.

Presentation on Tablet defects and it’s remedies.

Long Island University

Design and develop control release oral tablet using combination of different coating materials proportion and compare drug release profile data.

Presentation on liver enzyme effect on drug metabolism and disposition (Special enzyme CYP2A6).

Case study on design formulation for solid oral dosage form on different condition.

Education and Certification

Education:

Long Island University, New York, NY May-2017

Master of Science, Major: Industrial Pharmacy and cosmetic Science GPA: 3.56/4

Gujarat Technological University, Ahmadabad, India May-2013

Master of Pharmacy, Major: Quality Assurance GPA: 7.8/10

Awards/Certificate:

Got Graduate Employment Award in 2016-2017 from Long Island University.

A certificate of HPLC training from Molecular laboratory.

Got “investigator of the year” award during working in sun pharmaceutical for good observation on document review.

Having EHS training and Certificate during working in sun pharmaceuticals.

Contact this candidate