Summary
Overview
Work History
Education
Skills
Websites
Languages
Instruments Used
Personal Information
Work Preference
Timeline
Anil Payghan
Open To Work

Anil Payghan

Development Quality Assurence
Ahilyanagar,MH

Summary

Results-driven Pharmaceutical Quality Assurance and Analytical Professional with experience in Quality Assurance, Quality by Design (QbD), Analytical Development, and Pharmaceutical Regulatory Affairs within reputed pharmaceutical organizations. Experienced in the review and approval of MFRs, STPs, Specifications, SOPs, Qualification Documents, COAs, OOS/OOT investigations, Change Controls, CAPA, and other Quality Management System (QMS) activities. Currently working as a Development Quality Assurence Executive at Gufic Biosciences limited Research and Development Centre and previously associated with Lupin Limited in QbD and analytical functions.
Possess strong expertise in analytical testing of oral solids, ophthalmic, high-potent, contraceptive, and sterile pharmaceutical products, including assay, content uniformity, dissolution, degradation products, blend uniformity, particle size analysis, osmolality, viscosity, and HPLC calibration. Skilled in handling regulatory submissions, product permissions, import licenses, COPP applications, and interactions through ONDLS, MPFDA, and NSWS portals.
Proficient in operating and troubleshooting analytical instruments including HPLC, UV-Visible Spectrophotometers, Dissolution Testers, Karl Fischer Titrators, Malvern Particle Size Analyzers, Osmometers, and Viscometers. Well-versed in cGMP, GLP, data integrity, documentation practices, laboratory investigations, and regulatory compliance. Strong leadership, communication, problem-solving, and cross-functional collaboration skills with a proven ability to drive quality excellence and continuous improvement initiatives.

Overview

3
3
Languages
9
9
years of professional experience
7
7
years of post-secondary education

Work History

Development Quality Assurance Executive

Gufic Biosciences
Pithampur
03.2024 - Current
  • Review and approval of MFR, STP, Specifications, Qualification document and SOPs. Maintaining of record like LNBs, SOPs, STP, Specification and training record, issuance of control, un-control copy of various documents i.e. SOP, STP Specification, MFR.
  • Responsible for review of analytical data of in-process and finished data.
  • Responsible for review of HPLC Calibration Data.
  • Review of COA, investigation protocol and report of OOS and Laboratory Incidence.
  • Responsible for perform review, approval and ensure closing QMS activity like change control, CAPA, Incidence and other QMS activity.
  • Responsible for initiation, review and participating in investigation of quality management system such as change control, incidence, CAPA, OOS/OOT and non-conformance reports.
  • Additional Responsibility:
  • Applying import license for innovator sample From out of india.
  • Applying test license to FDA for new formulations for test and analysis.
  • Responsible for applying the brand name to FDA.
  • Responsible for applying the Product permission and COPP.
  • Responsible for applying Loan License.
  • Responsible for handling ONDLS, MPFDA and NSWS portal.

Executive Quality By Design (QbD)

Lupin Limited
Pithampur
01.2019 - 03.2024
  • Analysis of Scale up, QBD (trail) batches of OSD, Contraceptive and Ophthalmic products. Perform daily analysis of OSD high potent, Contraceptive Products, for various tests like Assay, Content Uniformity, Degradation product, Dissolution.
  • Perform daily analysis of Ophthalmic Products, for various tests like Assay, Blend Uniformity, Uniformity of Dosage, CCIT, Dissolution, EDTA, BKC, pH, Weight/ML, minimum fill volume Particle size Distribution By Malvern/ Nano Plus Globule Size, Viscosity and Osmolality, Degradation product.
  • Performing Calibration of HPLC.
  • Doing Online Documentation & Reporting of the samples analysed.
  • Reporting & Handling of Incidents, OOT, OOE and laboratory incident occurred during analysis.
  • Complete training on relevant SOPs and develop an understanding of the activities to be conducted prior to undertaking any task.
  • To follow the current GLP and cGMP in the laboratory.
  • Conduct all tasks/ activities as per the applicable SOPs.
  • Implementation and Simplification of SOPs.
  • Good team work & time management, Good analytical & logical approach.
  • Maintain the safety norms while working in lab.

Trainee (Apprentice)

Lupin Limited
Pithampur
08.2017 - 01.2019
  • Physical testing of Tablets, Capsules and Ophthalmic Product i.e in Tablets And Capsule: Description, Water Content, and Ophthalmic Product pH, Weight per ml, Osmolality, Minimum fill volume, Viscosity.
  • To follow the current GLP and cGMP in the laboratory.
  • Maintain the safety norms while working in lab.

Education

Master of Science - Analytical Chemistry

DadaPatil Rajale Arts And Science College, Pathardi
05.2015 - 06.2017
GPA: 64.18

Bachelor of Science - B.Sc

Pratishthan Mahavidyalaya, Paithan
05.2012 - 06.2015
GPA: 73.35

H.Sc - Science

New Arts, Commerce And Science College , Shevgaon
05.2009 - 06.2010
GPA: 44.00

S.Sc -

Abasaheb Kakade Vidyalay , Shevgaon
06.2007 - 05.2008

GPA: 57.53

Skills

  • E-Log Caliber
  • SAP
  • QAMS
  • Chromeleon 68
  • Chromeleon 73
  • Microsoft Excel
  • Microsoft Word
  • HPLC
  • UV-Visible Spectrophotometer
  • Dissolution Tester
  • PH Meter
  • Karl-Fisher
  • Malvern-Master Sizer
  • Nano Plus
  • Osmometer
  • Viscometer
  • Good Communication Skills
  • Presentation Skills
  • Self-motivated
  • Positive Mental Attitude
  • Creative Hard Work
  • Flexibility
  • Leadership Qualities
  • Multi-tasking Abilities

Languages

Marathi
Hindi
English

Instruments Used

  • HPLC (dinox Ultimate3000, Shimadzu, Prominence, Agilent) Software - Chromeleon 6.8 & 7.3
  • UV-Visible Spectro photometer:(Shimadzu. UV-1700,1800) Software UVprobe2.33.
  • Dissolution Tester : Make -Electro lab, Labindia.
  • PH Meter :(Thermo Orion/ Metrohm)
  • Karl-Fisher(KF) :(Metrohm -901Titrando) Software-Tiamo 2.4.
  • Malvern-Master Sizer
  • Nano Plus
  • Osmometer
  • Viscometer-Brookfield

Personal Information

  • Gender: Male
  • Marital Status: Married

Work Preference

Work Type

Full Time

Location Preference

On-Site

Timeline

Development Quality Assurance Executive - Gufic Biosciences
03.2024 - Current
Executive Quality By Design (QbD) - Lupin Limited
01.2019 - 03.2024
Trainee (Apprentice) - Lupin Limited
08.2017 - 01.2019
DadaPatil Rajale Arts And Science College - Master of Science, Analytical Chemistry
05.2015 - 06.2017
Pratishthan Mahavidyalaya - Bachelor of Science, B.Sc
05.2012 - 06.2015
New Arts, Commerce And Science College - H.Sc, Science
05.2009 - 06.2010
Abasaheb Kakade Vidyalay - S.Sc,
06.2007 - 05.2008
Anil PayghanDevelopment Quality Assurence