Nirbhay Pratap Singh
Sr Executive - Quality Control Aishwarya Lifesciences Pvt.Ltd. Lodhimajara Baddi (H.P)
Summary
Sr Executive of quality control department overseeing cGMP, GLP, and data integrity compliance in OSD and dry powder injection labs. Leads OOS, OOT, audit observation, CAPA, and laboratory change-control reviews while reviewing 5–10 batches daily for e-signatures, modification history, and release readiness, validating LIMS and OpenLab audit trails. Supports regulatory approvals by reviewing analytical data, e-signatures, and modification history with a compliance-first approach.
Overview
2
2
Languages
10
10
years of professional experience
Work History
Sr Executive of quality control department
Aishwarya Lifesciences Pvt Ltd.
09.2025 - Current
- Currently working at Aishwarya Lifesciences Pvt Ltd. Lodhimajara Baddi (H.P)
- Manufacturing Facilities: Dry powder injection and OSD (Oral Solid Dosage).
- Responsibility of Overall QC Compliance
- Providing the training and implementation of cGMP, GLP quality systems and compliance in the lab.
- Ensuring the there is no Data integrity/GLP violation with daily lab activity.
- Responsible to investigate the OOS, OOT and lab incident activity.
- Involved in response of Audit Observations.
- Involved in QC's SOP Review in Laboratory Information Management System (LIMS) application system.
- Involved and monitoring the Laboratory change control and CAPA review.
- Executed CAPA procedures following audit and investigation results.
- Responsible for execution of day to day GLP activity
- Actively involved and supported for getting approvals from different regulatory agencies like, South Africa-MCC, Brazil- ANVISA, CGMP, WHO. And MoH of countries like, Ukraine, New Zealand, Uganda and many others.
- Review all Analytical data along with (E-Signature) and modification history on open lab Software.
- Review of OPEN LAB Software Audit trails.
- 15September 2025 till date. as Sr Executive of quality control department.
Executive Worked as QC reviewer (finish products)
Vellinton Healthcare Kala amb
04.2024 - 08.2025
- Manufacturing Facilities: Ophthalmic, OSD (Oral Solid Dosage) and Ointment.
- Designation: Executive Worked as QC reviewer (finish products) in Vellinton Healthcare
- Responsibility of Overall QC Compliance.
- Involved in self inspection of Lab and other CFT as per schedule.
- Providing the training and implementation of cGMP, GLP quality systems and compliance in the lab.
- Ensuring the there is no Data integrity/GLP violation with daily lab activity.
- Responsible to investigate the OOS, OOT and lab incident activity.
- Involved in response of Audit Observations.
- Involved in QC`s SOP Review in DCS application system.
- Involved and monitoring the Laboratory change control and CAPA review.
- Responsibility of Implementation of CAPA as per Audit and Investigation.
- Responsible for execution of day to day GLP activity.
- Actively involved and supported for getting approvals from different regulatory agencies like, South Africa-MCC, Brazil- ANVISA, CGMP, WHO. And MoH of countries like, Ukraine, New Zealand, Uganda and many others.
- Review all Analytical data along with (E-Signature) and modification history on open lab Software.
- Review of OPEN LAB Software Audit trails.
- Period: March 2021 to March 2024
Sr. Officer Quality Control
Marine Medicare Pvt.Ltd.
03.2021 - 03.2024
- Manufacturing Facilities: Ophthalmic, OSD (Oral Solid Dosage) and Ointment.
- Worked as QC reviewer (finish products) in Marine Medicare Pvt.Ltd.
- Support for review and investigation for failure of analytical results / trends.
- SOP Trainings to Analysts as a part of On-Job training as per the SOP Training schedule.
- Review all Analytical data along with (E-Signature) and modification history on open lab Software.
- Responsible to review the online analysis activity.
- Actively involved and supported for getting approvals from different regulatory agencies like, South Africa-MCC, WHO . And MoH of countries like, Ukraine, Uganda and many others.
- Review of OPEN LAB Software Audit trails.
- Operating the LIMS Software (Laboratory information management system) and generating the Record of analysis for the Finished Products and other in-process products.
- To participate in the investigation of complaints related to the quality of products.
- Period: March 2021 to March 2024
Officer Quality Control
Digital vision Pharma kala amb
01.2017 - 02.2021
- Manufacturing Facilities: Dry powder injection, Tablet, capsule, Ointment.
- Worked as Q.C. Officer in (Analysis of Raw and Finished Products)
- Experienced in theoretical and practical knowledge in calibration, preventive.
- Maintenance, troubleshooting and problem solving of instruments like HPLC, UV Spectrophotometer ,FT-IR, KF Apparatus.
- Good interpersonal and communication skills.
- Responsible for complete analysis for Raw Materials and Finished goods.
- Periodical withdrawing of Stability Samples as per schedule.
Education
M.Sc. - Chemistry
01-2021
MCA - undefined
01-2015
B.Sc. - undefined
01-2010
Skills
OOS investigation
OOT investigation
Laboratory incident investigation
CAPA review
LIMS review
Change control management
Deviation management
cGMP compliance
GLP compliance
Data integrity review
SOP review
Audit observation response
Process validation
Stability study management
Quality risk management
SkillscGMP & GLP Implementation Data Integrity Assurance
Intumescent Manual HandlingHPLC (High-Pressure Liquid Chromatography) GC-MS (Gas Chromatography-Mass Spectrometry)FTIR Spectrometry (Extractive Fourier Transform Infrared) Disintegration Testing (DT) Friability TestingUV-Visible Spectrophotometry AAS (Atomic Absorption Spectroscopy) Dissolution TestingKarl Fischer Titration pH Meter Operation Polarimetry Analytical Data Review (Open Lab Software)LIMS (Laboratory Information Management System)
Declaration
I hereby declare that the information furnished above is true to best of my knowledge.
Instrument handling
HPLC (High-Pressure Liquid Chromatography) GC-MS (Gas Chromatography-Mass Spectrometry)
FTIR Spectrometry (Extractive Fourier Transform Infrared) Disintegration Testing (DT) Friability Testing
UV-Visible Spectrophotometry AAS (Atomic Absorption Spectroscopy) Dissolution Testing
Karl Fischer Titration pH Meter Operation Polarimetry Analytical Data Review (Open Lab Software)
LIMS (Laboratory Information Management System) cGMP & GLP Implementation Data Integrity Assurance
OOS/OOT Investigation CAPA Management Change Control Management SOP Development & Review
Instrument Calibration & Maintenance Regulatory Audit Response Stability Sample Management
Timeline
Sr Executive of quality control department
Aishwarya Lifesciences Pvt Ltd.
09.2025 - Current
Executive Worked as QC reviewer (finish products)
Vellinton Healthcare Kala amb
04.2024 - 08.2025
Sr. Officer Quality Control
Marine Medicare Pvt.Ltd.
03.2021 - 03.2024
Officer Quality Control
Digital vision Pharma kala amb
01.2017 - 02.2021