Niraj Sharma
Mandi
Summary
Dynamic Quality Control Manager with extensive experience at CIEL PHARMA PVT LTD, specializing in analytical method validation and instrument qualification. Proven track record in developing quality control procedures and leading teams to enhance product compliance. Adept at utilizing quality tools to mitigate risks while fostering a culture of continuous improvement.
Overview
18
18
years of professional experience
8
8
years of post-secondary education
1
1
Certification
Work History
Quality Control Manager
CIEL PHARMA PVT LTD
Baddi
03.2025 - Current
- Conducted inspections to ensure product quality and compliance with standards.
- Assisted in developing quality control procedures and guidelines for processes.
- Documented results of inspections and communicated findings to the team.
- Performing IQ, OQ and PQ of instruments.
- Handling of new projects related to Quality Control.
- Water system validation.
- Analytical Method Validation and Verification.
- Routine monitoring and planning of staff and samples of all the QC sections.
- Training to juniors.
- Process Validations.
- Cleaning Validations
- Auditing.
Quality Control Manager
Shubham Healthcare Pvt. Ltd.
Baddi
03.2024 - 03.2025
- Reporting to General Manager Operations about day to day activities of QC and Plan accordingly the Quality operations.
- Planning of work to all QC staff.
- Handling of all the QC sections, RM, PM, FG, Stability, Micro.
- Process Validations, Cleaning Validations, Analytical Method Validations, Water System Validations.
- Instrument Qualification and Calibrationand annual maintenance along with the engineering and other departments.
- Internal audits.
- Annual Product Quality Review, Stability summary Reports.
- Procurement of Lab Consumables.
Quality Control Manager
YASH LIFESCIENCES LTD
Lusaka
06.2019 - 08.2021
- Conducted inspections to ensure product quality and compliance with standards.
- Assisted in developing quality control procedures and guidelines for processes.
- Documented results of inspections and communicated findings to the team.
- Water System Validations, Installation Qualifications, Operational Qualifications, Operational Qualifications, Raise URS.
- Analytical Method Validations, Cleaning Method Validations, Process Validations, Cleaning Validations, Equipment Qualifications.
- Sample planning and assigning of work to QC staff.
- Approving and Rejecting the batches..
- Discuss to the Operational Director about new achievements and Weaknesses also about Quality Risk Factors and Corrective Actions.
- Handled HPLC (Waters, Shimdzu, Agilent), FTIR(Shimadzu), UV-Visible (Shimdzu), Dissolution apparatus, Karl Fischer, Autotitrator etc. And all other lab Instruments.
QC Executive
SUN PHARMACEUTICAL INDUSTRIES LTD
Baddi
03.2016 - 11.2018
- Review of documents and Instrumental Data.
- Handling of OOS and OOT results.
- HPLC ANALYSIS.
- Planning of Samples to analysts.
- Handling of Incidents and Deviations, Change Control, I vestigations and CAPA.
QC Executive
PANACEA BIOTEC LTD
Baddi
12.2014 - 11.2015
- Analysis of Raw Materials on HPLC, and Other Instruments.
- Complete analysis of active and inactive materials.
- Water analysis.
- Audit preparations
QC Executive
Zenufa Laboratories ltd
Dar-Es-Salaam
10.2013 - 02.2014
- Annual budget planning along with Qc manager.
- HPLC Analysis of RM, FG and In Process samples.
QC Officer
RANBAXY LABORATORIES LTD
Roopnagar
11.2010 - 08.2011
- HPLC (Waters) Handling.
- Analysis and reporting of in- process API of reactions stages.
- Hand over the charge to next shift.
Trainee Officer
PANACEA BIOTEC LTD
Baddi
02.2008 - 10.2010
- Sampling of Raw Materials and maintaining the records.
Education
MBA - Production
Madurai Kamaraj University
Sundernagar, INDIA 11.2008 - 12.2010
Master of Science - Pharmaceutical Sciences
Dolphin (PG) Institute of Biomedical And Natural Sciences
Dehradun , INDIA 05.2005 - 11.2007
Bachelor of Science - Chemistry
Himachal Pradesh University
Shimla, INDIA 03.2002 - 04.2005
Skills
- Quality control procedures
- Analytical method validation
- Instrument qualification
- Water system validation
- Usage of Quality tools to avoid Quality Risk Factors
- HPLC
- Microsoft Office
Languages
Hindi
First Language
English
Advanced (C1)
C1
French
Beginner (A1)
A1
Punjabi
Elementary (A2)
A2
Certification
- NATIONAL SERVICE SCHEME CERTIFICATE.
- LEAN SIX SIGMA YELLOW BELT.
- SADCAS (ISO 14000)
Personal Details
- DOB: 23/11/1984
- Marital Status: Married
- Father's Name: Dharam Prakash
- Address: Village and P.O. Reur, Tehsil Balh, District Mandi, H.P. PIN- 175023
Timeline
Quality Control Manager
CIEL PHARMA PVT LTD
03.2025 - Current
Quality Control Manager
Shubham Healthcare Pvt. Ltd.
03.2024 - 03.2025
Quality Control Manager
YASH LIFESCIENCES LTD
06.2019 - 08.2021
QC Executive
SUN PHARMACEUTICAL INDUSTRIES LTD
03.2016 - 11.2018
QC Executive
PANACEA BIOTEC LTD
12.2014 - 11.2015
QC Executive
Zenufa Laboratories ltd
10.2013 - 02.2014
QC Officer
RANBAXY LABORATORIES LTD
11.2010 - 08.2011
MBA - Production
Madurai Kamaraj University
11.2008 - 12.2010
Trainee Officer
PANACEA BIOTEC LTD
02.2008 - 10.2010
Master of Science - Pharmaceutical Sciences
Dolphin (PG) Institute of Biomedical And Natural Sciences
05.2005 - 11.2007
Bachelor of Science - Chemistry
Himachal Pradesh University
03.2002 - 04.2005