Manthan H Patel
Vapi
Summary
At Skant Healthcare Ltd, I spearheaded QC documentation, enhancing workflow efficiency by implementing Pharmacloud and Softsign, and ensuring regulatory compliance. My expertise in MS Office and exceptional communication facilitated cross-departmental collaboration, significantly improving audit readiness. I adeptly integrated updates from global pharmacopoeias, demonstrating a blend of technical proficiency and teamwork.
Overview
7
7
years of professional experience
Work History
Officer
Skant Healthcare Ltd
Vapi
06.2018 - Current
- Thoroughly reviewed, managed, and archived Quality Control (QC) documentation to ensure compliance with regulatory and organizational standards
- Maintained document traceability and updated records for internal and external audits
- Streamlined QC document workflows using Pharmacloud, Pharmasuit, and Document Management Systems (Softsign)
- Drafted and issued analytical protocols for Finished Products (FP), Raw Materials (RM), Process Validation (PV), and Stability Testing (ST)
- Designed and implemented Standard Test Procedures (STP) and Specifications (SPC) for FP and RM as per requirements from British Pharmacopoeia (BP), United States Pharmacopoeia (USP), European Pharmacopoeia (Ph
- Eur.), Indian Pharmacopoeia (IP), and International Pharmacopoeia (Ph
- Int.)
- Ensured all testing procedures adhered to regulatory compliance, industry guidelines, and customer requirements
- Raised and managed Change Control Forms (CCF) to reflect updates in SPC and STP documents as per pharmacopoeial standards or Contract Giver (CG) specifications
- Supported the creation of detailed compliance reports for regulatory audits and inspections
- Led initiatives to enhance the accuracy and efficiency of QC documentation and workflow processes
- Assisted in implementing corrective actions for non-compliance findings in QC audits
- Actively participated in regulatory and internal audits by presenting QC documentation and addressing auditor queries
- Ensured seamless communication between QC and other departments, aiding in pre-audit preparations
- Demonstrated proficiency in BP, USP, Ph
- Eur., IP, and Ph
- Int
- Requirements
- Maintained awareness of updates in pharmacopoeial standards and implemented necessary changes
- Coordinated with cross-functional teams to integrate QC practices into broader quality management systems
- Worked closely with manufacturing, R&D, and regulatory teams to ensure compliance with CG requirements
Education
MSC -
Mewar University
Rajasthan01.2020
B.S.C -
Jaipur National University
Rajasthan01.2018
H.S.C - Science
Bai Avabai Highschool
Valsad, Gujarat01.2012
S.S.C -
Bai Avabai Highschool
Valsad, Gujarat01.2010
Skills
- MS Office Word
- Excel
- PowerPoint
- Communication skills
- Teamwork and collaboration
- Presentation and manufacturing skills
Languages
- English
- Hindi
- Gujarati
Hobbies and Interests
- Cricket
- Carrom
- Volleyball
- Reading
- Listening to Songs
Disclaimer
I hereby declare that all the information provided in this application is actual and correct to the best of my knowledge and belief.
Areas Of Interest
- Quality Control
- Quality Assurance
Personal Information
- Father's Name: Hirubhai Ranchodji Patel
- Date of Birth: 09/08/94
- Gender: Male
Timeline
Officer
Skant Healthcare Ltd
06.2018 - Current
MSC -
Mewar University
B.S.C -
Jaipur National University
H.S.C - Science
Bai Avabai Highschool
S.S.C -
Bai Avabai Highschool
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