Himali Vyas
Calgary,Canada
Summary
Detail-oriented Procurement Specialist with 5 years of experience in Strategic Sourcing and Supply Management, specializing in USFDA submissions and quality management systems within the pharmaceutical industry. Demonstrated expertise in project management for ANDA submissions and post-approval change management, ensuring compliance and efficiency. Proven ability to thrive in fast-paced environments while managing multiple projects effectively. Committed to driving operational excellence and enhancing supply chain processes.
Overview
7
7
years of professional experience
Work History
Executive - Strategic Sourcing and Supply Management
Amneal Pharmaceuticals
Ahmedabad, India
01.2017 - 08.2021
- Managed sourcing and procurement of API for Amneal Global.
- Analyzed extensive Import and Export datasets applying online tools to benchmark API prices.
- Searched for vendors on USFDA and EDQM websites, focusing on their regulatory status.
- Evaluated vendor capabilities to reduce potential risks.
- Identified and approved vendors supporting DMF/CEP-grade APIs.
- Streamlined procurement process through the efficient use of ERP, and ensure timely delivery.
- Organized analytical and regulatory supporting documents from vendors until commercial product launch
- Maintained a key database for price approvals and other key responsibilities for the supervisor's review.
- Managed end-to-end project coordination, ensuring resolution of document and material quality issues.
- Facilitated execution of CDA in collaboration with Amneal legal team to secure confidential documents from vendor.
- Initiated VAQ technical and quality agreements for API, excipient, and packaging materials.
- Monitored vendor modifications, communicated those changes to all internal stakeholders, and ensured the generation of Change Control and its successful closure to ensure uninterrupted commercial procurement.
- Issued Purchase orders and coordinated with logistics team for in-warding concerns through ERP.
- Streamline the Bill of Entry process by collecting and arranging essential paperwork including Commercial Invoices and custom-required labels.
- Continuously enhanced proficiency in different ICH guidelines and USFDA standards by collaborating with internal teams.
- Acquired impurities essential for conducting analytical research and development.
- Conducted calls and meetings to ensure vendor alignment with project objectives.
- Facilitated interactions at CPhI India and Worldwide to develop efficient lines of communication.
- Ensure accurate maintenance of official Client COA and Specification/MOA in the Logistics database.
- Managed and updated savings records consistently.
- Quarterly updates provided to vendor after reviewing input from Sales and Marketing teams.
- Coordinate with finance department to ensure vendor payments align with listed terms.
- Ensured vendor compliance with 2019 USFDA Nitrosamine Guidelines.
Officer- Formulation and Development for Oral Solid
Amneal Pharmaceuticals
Matoda, India
11.2014 - 12.2016
- Assisted in RM verification, granulation, and coating processes.
- Completed manufacturing following BMR guidelines.
- Conduct thorough monitoring of in-process checks for effective process validation.
- Oversaw online documentation for production activities, including BMR and log book.
- Compiled detailed PDR documentation for internal use.
- Ensured up-to-date equipment qualification.
- Ensured efficient batch segregation, identification, and labeling.
- Monitored yield control during multiple production phases.
- Managed environmental controls in production area.
Education
Post-Diploma - Health and Human Services Management
Bow Valley College
Calgary, Alberta08.2022
Master of Pharmacy - Pharmaceutical Technology
Gujarat Technological University
India12.2016
Bachelor of Pharmacy -
Gujarat Technological University
India10.2013
Skills
- Project management
- Negotiation skills
- Strategy development
- Time and resource optimization
- Quality management
- Vendor partnerships
Timeline
Executive - Strategic Sourcing and Supply Management
Amneal Pharmaceuticals
01.2017 - 08.2021
Officer- Formulation and Development for Oral Solid
Amneal Pharmaceuticals
11.2014 - 12.2016
Post-Diploma - Health and Human Services Management
Bow Valley College
Master of Pharmacy - Pharmaceutical Technology
Gujarat Technological University
Bachelor of Pharmacy -
Gujarat Technological University
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