Suraj Mandhare
Summary
Highly motivated and detail oriented Quality Control Analyst with 7 years of experience in the pharmaceutical industry. Excellent technical and analytical skills. First-rate problem-solving abilities and am quick to identify problem areas, diagnose root causes, and implement corrective actions. Proven track record of ensuring compliance with regulatory requirements and improving quality control process.
Overview
7
7
years of professional experience
1
1
Certification
Work History
Senior Quality Control Officer
Oman Pharmaceutical Product Co. LLC
07.2023 - Current
- To ensure the GLP activity within the laboratory.
- To performed all review related activities and routine activities as per data integrity compliance.
- Analysis and reporting of raw material,stability samples and finish products.
- Maintaining online documentation for the analysis conducted in lab.
- Providing analytical support to the production department.
- Performing daily follow as per ALCOA++,GDP,GLP,cGMP,21 CFR part 11.
- Investigation of OOS,OOT,laboratory incident.
Quality Control Executive
Torrent Pharma Ltd.
12.2021 - 05.2023
- Primarily responsible for the QMS activities pertaining.
- To performed all review related activities and routine activities as per data integrity compliance.
- Online sequence review of the HPLC,GC and other with the online review of the sample solution.
- Investigation of OOS,OOT and laboratory incident.
- Handling of deviation,change control,CAPA and OOS,OOT and manufacture investigation in paper based logging investigation writing impact assessment and closure.
Quality Control Officer
Hikal Ltd.
05.2019 - 05.2021
- Analysis and reporting of raw material,stability samples and finish products.
- Carrying out analysis of intermediate sample and SRU sample.
- Providing analytical support to the production department.
- Maintaining online documentation for the analysis conducted in lab.
- To ensure the GLP activity within the laboratory.
Junior Associate Quality Control
Choksi Laboratory Ltd.
12.2017 - 05.2019
- Maintaining good laboratory practices.
- Carrying out the analysis by using proper PPEs.
- Expert in wet lab (ROI,LOD,IR,UV,KF,TLC)
- Calibration of instrument like analytical Balance, PH meter.
Education
Master of Science - Organic Chemistry
Someshwar Science Collage Baramati Pune University
Baramati Pune10-2017
Bachelor of Science - Chemistry
KVM, Shivaji University
Wai03-2015
Skills
- Quality control and assurance
- Pharmaceutical regulations (cGMP,FDA,EU,GMP)
- Laboratory testing and analysis (HPLC,GC,TLC,UV,KF)
- Quality control software (Chromeleon,Empower,Lab solution,Open lab,SAP)
- Microsoft Office(Excel,Word,Powerpoint)
Technical Skill -
- Able to work accurately & efficiently under pressure
- Behavioral management
- Safety awareness
- Time management
Acquired Skill -
Certification
Major Contents Of Course
- Theoretical concept - GLP,GDocP,GMP,cGMP (with respect to regulatory guideline) 21 CFR part 11,Data integrity,chromatography,HPLC theory. laboratory practice(GLP)-FDA recognized provider.
- Practical Skill set with respect to pharmaceutical testing techniques with independent operation.
- Basic techniques - Weighing,dilution,operation and calibration.
- Overview of concept - Change control,Deviation,root cause,OOS,OOT,incident.
Additional Information
Personal Profile
- Name - Suraj
- Gender - Male
- Date of birth - 03 Nov 1994
- Marital status - Unmarried
- Nationality - Indian
- Languages known - English,Hindi,Marathi.
Declaration
I hereby declare that the information furnished above is true to the best of my knowledge.
Date :
Place :
Timeline
Senior Quality Control Officer
Oman Pharmaceutical Product Co. LLC
07.2023 - Current
Quality Control Executive
Torrent Pharma Ltd.
12.2021 - 05.2023
Quality Control Officer
Hikal Ltd.
05.2019 - 05.2021
Junior Associate Quality Control
Choksi Laboratory Ltd.
12.2017 - 05.2019
Major Contents Of Course
- Theoretical concept - GLP,GDocP,GMP,cGMP (with respect to regulatory guideline) 21 CFR part 11,Data integrity,chromatography,HPLC theory. laboratory practice(GLP)-FDA recognized provider.
- Practical Skill set with respect to pharmaceutical testing techniques with independent operation.
- Basic techniques - Weighing,dilution,operation and calibration.
- Overview of concept - Change control,Deviation,root cause,OOS,OOT,incident.
Master of Science - Organic Chemistry
Someshwar Science Collage Baramati Pune University
Bachelor of Science - Chemistry
KVM, Shivaji University
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