Vikrant Gupta
ASTT. MANAGER QC
Jammu
Summary
Quality Control Manager leading release testing, review of analytical data, and coordination of QC sections across raw materials, packing materials, finished products, and stability samples. Directs GLP compliance, instrument audit trails, root-cause investigations, document control, and 10+ analyst training sessions per month while keeping daily department planning on track. Supports certification, regulatory readiness, and timely closure of quality issues through structured review and follow-up.
Overview
1
1
Language
20
20
years of professional experience
Work History
Astt. Manager
Ravenbhel Healthcare Pvt. Ltd.
10.2021 - Current
- Track [number] audit records per sprint for faster retrieval during internal, external, and regulatory inspections.
- Maintain [number]% QC equipment uptime across routine calibration, troubleshooting, and instrument readiness.
- Lead QC release activities for raw materials, packing materials, semi-finished goods, finished products, and stability samples.
- Manage QC team coordination for certification, analytical incidents, OOS, and OOT investigations, using root cause analysis and deviation management.
- Train newly joined analysts and QC staff on systems, SOPs, and yearly development plans.
- Review documents, audit trails, and regulatory responses while supporting gap analysis and document control.
- Use ERP systems to record results online, monitor process validations, and support analytical method validation and calibration timelines.
Executive
Sun Pharma Laboratories Pvt. Ltd.
12.2013 - 10.2021
- Run stability checks for intermediate and finished products in line with regulatory requirements.
- Review analytical reports per week to support SOP updates, root cause analysis, and regulatory responses.
- Analyze raw material, in-process, and finished product samples to support routine quality release decisions.
- Calibrate HPLC, UV, and dissolution instruments when required, maintaining readiness for critical laboratory testing.
- Handle LIMS software to manage analytical records and support laboratory data tracking.
Executive in F&D
Ravenbhel Healthcare Pvt. Ltd.
01.2011 - 12.2013
- Reviewed new formulated, bulk, semi-finished, and finished samples to verify quality before progression.
- Conducted soft gelatin capsule analysis and coordinated cross-functional support for validation protocols, reports, and data trending.
- Participated in international and other quality audits, preparing supporting documents for QC department reviews.
- Documented post-training observations for employees and technicians after onboarding sessions.
- Analyzed root causes across QC issues and translated findings into validation and trend review support.
Officer in Quality Control
Emcure Pharmaceuticals Limited
11.2007 - 07.2009
- Prepared and standardized volumetric solutions to support analytical testing and routine laboratory operations.
- Reviewed SOPs, specifications, qualification protocols, and analytical data sheets for laboratory compliance.
- Maintained daily QC planning and follow-up across department activities to keep testing work organized.
Tech. Supervisor in Quality Control
Cadila Pharmaceuticals Limited
06.2006 - 10.2007
- Analyze finish products and raw materials for routine quality checks and batch-release support.
- Prepare and standardize volumetric solutions used in sample analysis and laboratory testing.
- Document results and review SOPs, specifications, qualification protocols, and analytical data sheets for accuracy.
Education
PGDPRA Diploma - Drug Regulatory Affairs
Jamia Hamdard University
New Delhi06-2013
Master of Pharmacy - Pharmacology
Uttarakhand Technical University
Dehradun, Uttarakhand08-2012
Bachelor of Pharmacy - Pharmacy
Punjab Technical University
Jallandar07-2006
Skills
Quality control
Root cause analysis
Audit management
Deviation management
CAPA management
Change control
Document control
Quality agreement management
ICH Q9 risk assessment
Audit management
Stability testing
Method validation
Analytical instrument calibration
Analytical method transfer
LIMS software
SAP
Technical Skills
ERP systems
Data integrity
Laboratory information management
Interests
Hobbies : Reading Literature , Cricket & Listening soft music
CAREER CONTOUR
- Since Oct 2021 to till date with Ravenbhel Healthcare Pvt. Ltd. Jammu. as Senior Executive, Quality Control
- Heading the Finished Good , Packing material, Raw Material section from time to time .
- Managing QC team for analysis in view of certification and release of Raw materials, Packing Materials, Semi-finished , Finished product and Stability Products.
- Conduct of training to newly joined analysts on system and SOPs. Reviewing documents generated for responding queries from different regulatory authority. Providing support for gap analysis.
- Ensuring that the appropriate process validations, including those of analytical procedures and calibrations of quality control equipments/instruments are carried out on timely basis.
- To ensure the all analytical incidence, OOS and OOT as per requirements.
- Performing Audit of commercial analytical laboratories and Vendor Manufacturing sites. Involved in Internal/External Audits and supporting Regulatory Audits; arranging the entire documentation for easy retrieval during regulatory audits.
- Conducting training as per yearly schedule and as required for self-development of all QC staff.
- Troubleshooting of instruments.
- Review the Audit Trial reports.
- Working with ERP System for online recording of results and release of materials.
- Audits Handled: Ethiopia, Uganda ,Kenya, Tanzania ,J&J & Philipines; WHO-India; Russia
- Review of various documents like SOPs, Specifications, qualification protocols, and analytical data sheets.
- Daily work planning and follow up of whole QC department.
Timeline
Astt. Manager
Ravenbhel Healthcare Pvt. Ltd.
10.2021 - Current
Executive
Sun Pharma Laboratories Pvt. Ltd.
12.2013 - 10.2021
Executive in F&D
Ravenbhel Healthcare Pvt. Ltd.
01.2011 - 12.2013
Officer in Quality Control
Emcure Pharmaceuticals Limited
11.2007 - 07.2009
Tech. Supervisor in Quality Control
Cadila Pharmaceuticals Limited
06.2006 - 10.2007
Bachelor of Pharmacy - Pharmacy
Punjab Technical University
Master of Pharmacy - Pharmacology
Uttarakhand Technical University
PGDPRA Diploma - Drug Regulatory Affairs
Jamia Hamdard University