C R PUNITH KUMAR
Assistant Manager- QA & RA
AVADI
Summary
Professional with strong background in quality assurance and proven track record of ensuring product excellence. Adept at utilizing Quality tools and implementing corrective actions. Known for effective collaboration, adaptability, and consistently delivering results in fast-paced environments. Skilled in test planning, execution, and documentation, with focus on maintaining high standards.
Overview
4
4
years of professional experience
3
3
years of post-secondary education
4
4
Languages
Work History
Assistant Manager- QA & RA
K.P. Manish Global Ingredients Pvt Ltd
04.2021 - Current
- Experience in Quality Assurance documentation system and control
- Preparation of SOPs and its maintenance
- Change control system and notification, Deviation/ Incidents logging
- Coordination with Physical Site audits and Virtual Audits at Warehouse.
- Vendor Qualification and requalification process
- Preparation of CAPA, Root Cause Analysis (RCA) along with 5 Why analysis and Fishbone Diagram
- Training of Warehouse and QA Team
- Licensing and Renewal process
- Drug License registration and renewal, Import Registration for different branches and different warehouses
- FSSAI Licensing and renewal
- FSSAI Form-II approval process and registration for more than 5 products
- DMF review and preparation along with DMF related documents
- Process Validation, Analytical method validation, Stability Summary
- Technical Services on testing for various Physicochemical and microbiological parameters at external laboratories and auditing the facilities
- Invoicing and payment tracking for the testing services
- Review of Quality documents like Site Master File, HACCP Plan, Quality policy and other relevant declarations and statements
Education
Ph.D. - Pharmaceutical Phytochemistry
Sri Ramachandra Institute of Higher Education And Research
Chennai, India 04.2023 - Current
Pharmaceutical Chemistry
C.L. Baid Metha College of Pharmacy
Chennai, Tamil Nadu 04.2021 - 12.2021
B. Pharmacy - Pharmacy
C.L. Baid Metha College of Pharmacy
Chennai, Tamil Nadu 04.2019 - 12.2019
Skills
Quality assessment skills
Regulatory compliance expertise
Process Validation
Analytical Method Validation
Quality Management System
Vendor Qualification
Quality System Implementation
SAP
Internal Audits
Change Control
Interests
Frequent information gatherer on Artificial Intelligence
Cooking
Playing Chess and Badminton
Debating
Skimming News feed and social network
Personal Information
Date of Birth: 07/24/98
Publications
- Artificial Intelligence in healthcare: a brief review, Suranaree Journal of Science and Technology, 03/01/22, 29, 2
- Pharmacological and chemical potential of caesalpinia bonducella: a critical review, International Journal of Science and Research (IJSR), 10/01/23, 12, 10
- Pharmacological and Biological Activities of Azetidinone models: A Brief Overview, International Journal of Science and Research (IJSR), 10/01/23, 12, 10
Training
- QBD
- Six Sigma
Significant Highlights
- Worked on Elderberry extract syrup for kid's formulation which was launched in UK Market by Apex Laboratories, Chennai
- FSSAI Form- II approval process successfully completed for 2-Fucosyl lactose, an HMO (Human Milk Oligosaccharide) used in Infant formulations by Abbott
- FSSAI Form-II approval process successfully completed for D-Chiro Inositol in FSMP (Food for Special Medical Purpose) for PCOD complaint women by Dr. Reddys Laboratories.
Software
CRM
DMS
SAP
Timeline
Ph.D. - Pharmaceutical Phytochemistry
Sri Ramachandra Institute of Higher Education And Research
04.2023 - Current
Pharmaceutical Chemistry
C.L. Baid Metha College of Pharmacy
04.2021 - 12.2021
Assistant Manager- QA & RA
K.P. Manish Global Ingredients Pvt Ltd
04.2021 - Current
B. Pharmacy - Pharmacy
C.L. Baid Metha College of Pharmacy
04.2019 - 12.2019