KRUPA PANDYA
Clayton South
Summary
Motivated Quality Control Chemist offering with a demonstrated work history in the GMP, USFDA, TGA and MHRA certified pharmaceutical industry. Strong quality control and quality assurance skills in deriving laboratory tests and maintenance of Quality Management System.
Overview
9
9
years of professional experience
Work History
Quality Control Chemist
Nanokote
01.2022 - Current
- Designing and completing lab experiments to support quality control objectives
- Assessment and Release of Raw Materials for use in production. Conditional release of Raw Materials and intermediate products after QC testing.
- Ensuring Good Documentation Practices (GDP) and Good Laboratory Practices (GLP) in QC Lab.
- Monitoring of Quality Control procedures and Lab methods for testing of Finished products.
- Ensuring Finished products are meeting the customer requirements and complying regulatory standards.
- Creating reports by observing, analyzing, and interpreting lab experiment results
- Participated in product quality development by working in team
- Ordered supplies, inventoried chemicals and materials and summarized and recorded data to meet control and research requirements
- Monitored packaging and storage of hazardous materials and waste to comply with safety regulations
- Maintained, cleaned, and labeled laboratory equipment, tools, chemicals and solutions properly
- Formulated and tested product functionality to meet specified requirements and long-term success
- Juggled multiple projects and tasks to ensure high quality and timely delivery
- Assist with investigations and root cause analysis.
- Maintenance and continuous improvement of the Quality Management System
- Prepared and Reviewed SOPs and put efforts in implementing the SOPs
Quality Assurance (Senior Officer)
SUNPHARMA PHARMACEUTICAL MEDICARE LIMITED
10.2016 - 01.2019
- Prepared and Reviewed Annual Product Quality Review for Domestic and Export market
- Prepared Product Quality Assessment Reports by statistical evaluation for Domestic and Export market
- Prepared, Reviewed and Issued Standard Operating Procedures (SOPs) for Quality Assurance
- Provided on-the-floor Quality Support to Manufacturing, including real-time observation of activities to ensure compliance
- Provided recommendations on ways to improve or update existing QC standards
- Provided assessments of the overall quality of production and distribution processes by carrying out Good Documentation Practice (GDP) Audits
- Enforced adherence to cGMPs, SOPs, and documentation for all manufacturing operations and Quality Control tests
- Handled planned deviations and tracked open CAPA, and Change controls
- Prepared reports and documents required by various regulatory agencies
- Played a role of Scribe and assisted the Auditor during Quality Control Laboratory round
- Reviewed executed Batch Records to ensure regulatory compliance.
- Aided new members of the quality assurance team during orientation process
- Prepared presentations and meeting reports for Quality circle
- Represented Sun Pharma in National competition of Quality circle
- Maintained up-to-date knowledge of company and federal regulations to drive product quality, consistency, and compliance
Trainee
SUNPHARMA PHARMACEUTICAL MEDICARE LIMITED
07.2016 - 10.2016
- Gained strong knowledge about core Pharmacy principles, Quality Management System, methodologies, and tools
- Developed a skill to use different laboratory instruments and systems
- Performed the required daily analytical work for the efficient, effective and safe operations
- Ensured that the laboratory and equipments are well maintained
- Supervised other laboratory staff and assessed technical skills of students
- Solved case studies related to product quality
- Grasped new materials, processes and programs quickly to maximize performance
- Updated personal notes and permanent records with observational details
Education
Master of Pharmacy - Pharmaceutics
Uka Tarsadia University
01.2016
Bachelor of Pharmacy -
Maliba Pharmacy College
01.2014
HSC - Science
GHSEB
01.2010
SSC -
J. H. Ambani - Reliance Group of Schools
01.2008
Skills
- Outstanding working experience with industry leaders in GMP and ISO certified large scale pharmaceutical company
- Strong understanding of regulatory requirements in TGA, USFDA and MHRA
- Organizational and planning skills
- Time Management
- Ability to meet strict deadlines
- Quality standards
- Problem Solving
Accomplishments
- Certification for 'Avoiding Pharmaceutical Data Integrity Problems', Sun Pharma Technical Training Academy, 2016
- Certification for 'Intellectual Property Rights', World Intellectual Property Organization, 2015
- Training on 21st century Quality Improvement by Statistical Application, Light Pharma, 2018
- Awarded with the scholarship by State Examination Board, Gujarat, 2003
- Honoured as a best teaching leader in Tribal coaching program held at Swaraj Aashram, Bardoli, Gujarat, 2010
Timeline
Quality Control Chemist
Nanokote
01.2022 - Current
Quality Assurance (Senior Officer)
SUNPHARMA PHARMACEUTICAL MEDICARE LIMITED
10.2016 - 01.2019
Trainee
SUNPHARMA PHARMACEUTICAL MEDICARE LIMITED
07.2016 - 10.2016
Bachelor of Pharmacy -
Maliba Pharmacy College
HSC - Science
GHSEB
SSC -
J. H. Ambani - Reliance Group of Schools
Master of Pharmacy - Pharmaceutics
Uka Tarsadia University
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