LIMS
Ishan Gajera
Quality Control Chemist
Craigieburn,Australia
Summary
Versatile Senior Officer in Pharmaceutical Quality Control and skilled at Analysis of Tablets, Capsules, Injections, Syrup, Suspensions & Dry powder products along with that working on planning, implementing and overseeing key improvements through QMS activities to drive compliance practice in QC lab. History of cultivating an open culture with free exchange of information. Pursuing new professional challenges with a growth-oriented company.
Overview
5
5
years of professional experience
8
8
years of post-secondary education
Work History
Sr. Officer Quality Control
Biomatrix Healthcare PVT LTD
Ahmedabad, Gujarat, India
08.2021 - 02.2023
- Worked as a QMS designee and performed investigations for Laboratory incidents and OOS results.
- Recommended and implemented successful strategies to minimize QMS activities such as laboratory incident & OOS .
- Conceived and oversaw Laboratory compliance special projects to make lab ready for EUGMP.
- Directed work of In process section analysts, monitoring product quality, compliance and productivity.
- Reviewed and analyzed analysis reports, records and directives to obtain data required for planning department activities.
- Managed large-scale projects for regulatory audits and introduced new systems, tools, and processes to achieve compliance in laboratory.
- Boosted team member productivity by enhancing performance monitoring and instituting motivational approaches.
- Identified cost improvement changes and cost savings plans to increase company savings.
- Ordered new equipment and inventory and scheduled repairs for damaged equipments under GLP terms.
- Consolidated vendors and renegotiated contracts to optimize costs.
- Provided strong leadership to enhance team productivity and morale to manage product release process within time frame.
- Implemented and developed good laboratory practices in laboratory through annual training schedule.
Quality Control Officer
Intas Pharmaceuticals (Known As Accord Healthcare)
Ahmedabad, Gujarat, India
12.2019 - 08.2021
- Worked as a senior HPLC analyst in in-process section and performed analysis of Related substances, organic impurities, assay & dissolution test on HPLC instruments for various forms of medicine such as tablets, capsule, injection, Lyophilized Powder for Injection for Oncology drugs.
- Along with this Performed shift in-charge roll of 6 QC analyst and managed laboratory analysis trouble shooting and supervised and directed team work under GLP terms.
- Trained newly appointed shift members for good analysis skills for USFD approve plant.
Quality Control Associate
Baxter Pharmaceuticals
Ahmedabad, Gujarat, India
04.2019 - 12.2019
- Worked as a GLP designee and performed various laboratory instrument calibrations from minor instrument like pH & balance to critical instruments such as HPLC & TOC.
- Performed routine analysis of SVP products on HPLC instrument in-process section.
- Completed allocated analysis with in time frame by following GLP & GDP terms using all kind of instruments such as HPLC, TOC, IR, UV, Refractometer etc.
QC Trainee
Ratnamani Healthcare PVT LTD
Ahmedabad, Gujarat, India
12.2017 - 04.2019
- Proved successful working within tight deadlines and a fast-paced environment.
- Learned and adapted quickly to new instruments and software applications.
- Gained strong analysis skills by managing allocated work from start to finish.
- Developed and maintained courteous and effective working relationships.
- Became veteran HPLC analyst with great technical & trouble shooting knowledge.
- Developed expertize in different instruments such as UV, Dissolution, IR, TOC, pH meter, Conductivity meter, hardness tester, friability tester, disintegration tester etc.
Education
Master of Science - Organic Chemistry
M.M.Patel Institute of Sciences & Researches
KSV University, India 06.2016 - 04.2018
Bachelor of Science - Chemistry
C.U.Shah Science College
Gujarat University, India. 06.2013 - 04.2016
High School - 12th Science With PCM Group
Gujarat Higher Secondary Board
Gujarat, India 04.2011 - 04.2013
SSC -
Gujarat Secondary Board
Gujarat, India 04.2010 - 04.2011
Skills
Analytical skills
Accomplishments
- Supervised team of 9 analyst and manged routine analysis and review procedure along with daily trouble shootings.
- Documented and resolved analytical errors which led to Lab Incident & OOS results.
- Got rewarded for good work in MHRA audit of October 2019 at Baxter Pharmaceutical, India.
- Faces many regulatory audits such as USFDA, MHRA etc in MNC companies like Baxter & Intas pharmaceuticals.
- Recently worked as QMS designee and performed key role in compliance cell to pass out 7 ROW audits in 8 month timeframe such as Ethiopia,Ghana,Uganda,Yamen,Kenya,Malawi & Brazil.
- Worked on compliance project and made effective changes in laboratory practices to make laboratory ready for EUGMP at Biomatrix Healthcare site.
Software
CHROMELEON 72 & 68 HPLC SOFTWARE
LAB SOLUTION HPLC SOFTWARE
QEDGE QMS SOFTWARE
PHARMACLOUD QC LABORATORY SOFTWARE
Instrument Knowledge
- HPLC (Shimazdu LC-2010 to LC-2050, Thermoscientific Ultimate 3000, Agilent 1100 series)
- Dissolution
- UV spectrophotometer
- IC
- FTIR
- TOC
- AAS
- Physical parameter instruments such as Friability, DT, Hardness, pH, Balance.
References
- Priyanshi Patel
Technical Peer Support at Services at Australia-Serco Pty. Ltd
Contact 0405654806
- Nilesh Patel
QC General Manager at Biomatrix Healthcare PVT LTD, India
Contact +91-6358970505
Timeline
Sr. Officer Quality Control
Biomatrix Healthcare PVT LTD
08.2021 - 02.2023
Quality Control Officer
Intas Pharmaceuticals (Known As Accord Healthcare)
12.2019 - 08.2021
Quality Control Associate
Baxter Pharmaceuticals
04.2019 - 12.2019
QC Trainee
Ratnamani Healthcare PVT LTD
12.2017 - 04.2019
Master of Science - Organic Chemistry
M.M.Patel Institute of Sciences & Researches
06.2016 - 04.2018
Bachelor of Science - Chemistry
C.U.Shah Science College
06.2013 - 04.2016
High School - 12th Science With PCM Group
Gujarat Higher Secondary Board
04.2011 - 04.2013
SSC -
Gujarat Secondary Board
04.2010 - 04.2011
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