Caliber QAMS
Sachin Kumar
Quality Assurance
Saharanpur
Summary
Seeking a challenging position in well-established Pharmaceutical Company that offers professional growth and ample opportunity to learn and enrich my competencies in my profession.
Dynamic professional with 12 years of experience in Quality Assurance Departments, presently associated with Gracure Pharmaceutical Limited, Bhiwadi Rajasthan, as Assistant Manager- QA.
Overview
12
12
years of professional experience
3
3
Certifications
1
1
Language
Work History
Assistant Manager-QA
Gracure Pharmaceutical Limited
02.2026 - Current
- To Lead Quality Assurance team.
- To handle Change control, Deviation, & CAPA.
- To ensure the regulatory compliance (i.e. EU-GMP, TGA, Health Canada WHO, CDSCO) etc.
- To perform self inspection of GMP facility as lead auditor.
- To timely batch release for commercial products.
- Handling of Audit & inspection of regulatory agencies as well as customer audit.
- To review & approve Quality Risk Assessment.
- To handle the market complaints and product recalls.
- To monitor the shop floor activities.
- To review & approve the cleaning validation protocol & report.
- To review & approve the process validation protocol & report.
- To review & approve the Hold time study protocol and report.
- To review & approve Scale up Protocol and report.
- Exposure of Quality Audits: USFDA, EU-GMP, (Hungary, Croatia) MHRA, TGA, ANVISA, MCC South Africa, ISO, MOH Ukraine and CDSCO-INDIA.
Senior Executive-QA
Mankind Pharma Limited, Unit-2
06.2021 - 02.2026
- To prepare & review Quality Risk Assessment.
- To monitor the shop floor activities.
- To prepare & review the cleaning validation protocol & report.
- To prepare & review the process validation protocol & report.
- To prepare & review the Hold time study protocol and report.
- To prepare & review Scale up Protocol and report.
- Responsible monitoring of equipment qualification and periodic requalification.
- Planning & management of validation activities in coordination with CFT’s to meet timely execution of validation batches & to fulfill requirements of release & dispatch of commercial products.
- To perform self inspection of GMP facility as lead auditor.
- As certified trainer ensuring the training program within team along with CFT’s to adhere the cGMP practices in their work.
- Reviewing existing processes and re-designing the same.
- To Participate in Technology transfer from R&D personals for the Scale up, Optimization, Exhibit and Validation of batches.
Executive (QA)
Jubilant Generics Ltd.
08.2018 - 06.2021
- Overall accountable for shop floor activities & distributed work to their subordinate as IPQA Shift In charge
- To perform in-process in manufacturing at different stages as well as Packing.
- To prepare & review of cleaning validation protocol.
- To review exhibit and process validation protocol.
- To review Hold time study protocol.
- To collect swab & rinse samples
- Line clearance activity for Dispensing of Raw Material/Packing material as well as Manufacturing & Packaging Operation.
Officer (QA)
Windlas Healthcare Pvt. Ltd.
08.2017 - 07.2018
- Reviewing of batch manufacturing record, batch packaging record and analytical reports prior to release of product.
- Line clearance activity for Dispensing of Raw Material/Packing material as well as Manufacturing & Packaging Operation.
- Validation team member & co-ordination for execution of Process & Cleaning Validation & Hold Time Protocols & Report.
- To Prepare the SOP related to shop floor activities.
- To give line clearance at various stage of manufacturing & packaging.
Sr. Officer (QA)
Tirupati Life sciences
08.2016 - 07.2017
- To give line clearance at various stage of manufacturing & packing.
- Hold time study sample management.
- To perform in process checks at various stage of manufacturing & packing.
- To collect cleaning verification and cleaning validation sample.
- Operating and calibration of IPQA instruments.
- To collect cleaning verification and cleaning validation sample.
Junior Officer (QA)
Windlas Biotech Ltd.
08.2014 - 07.2016
- To give line clearance at various stage of manufacturing & packing.
- To perform in process checks at various stage of manufacturing & packing.
- Line clearance during dispensing of raw materials and packing materials.
- Q.A verification during dispensing of raw materials and packing materials.
- Operating and calibration of IPQA instruments.
- Reviewing of batch manufacturing record, batch packaging record and analytical reports prior to release of product.
Education
B. Pharmacy -
IEC College of Eng. & Technology
Gr. Noida01-2014
Skills
Ability to learn new skill very fast, quick learner and good observer
Self-Confident
Software
SAP
EDMS
Track & Trace
Certification
Yellow Belt Certified
DECLARATION
I hereby solemnly declare that all above said information about me is fully correct to the best of my knowledge.
PERSONAL DETAILS
- Date of Birth: 1989-02-02
- Address: Vill- Suwakhari, Post- Saraswa, Dist- Saharanpur, State- Uttar Pradesh, Pin No- 247232
- Marital Status: Married
Timeline
Assistant Manager-QA
Gracure Pharmaceutical Limited
02.2026 - Current
GMP Auditor
10-2025
Lean Tool Practitioner
05-2024
Yellow Belt Certified
07-2023
Senior Executive-QA
Mankind Pharma Limited, Unit-2
06.2021 - 02.2026
Executive (QA)
Jubilant Generics Ltd.
08.2018 - 06.2021
Officer (QA)
Windlas Healthcare Pvt. Ltd.
08.2017 - 07.2018
Sr. Officer (QA)
Tirupati Life sciences
08.2016 - 07.2017
Junior Officer (QA)
Windlas Biotech Ltd.
08.2014 - 07.2016
B. Pharmacy -
IEC College of Eng. & Technology