Harshad Patel
Caledon,ON
Summary
A Resourceful, Performance driven and detail-oriented Quality and Regulatory affairs professional with 7+ years of experience overseeing quality and compliance for leading pharmaceutical and medical device companies. Offering dynamic research, analytical and Project Management skills with proven expertise in monitoring Manufacturing activities and ensuring compliance with quality and regulatory regulations. Determined Quality Assurance Specialist with dedication to quality and accuracy. Familiar with handling multiple projects in highly competitive environments. Solid interpersonal and collaboration skills.
Overview
11
11
years of professional experience
Work History
Senior Quality Associate II, Batch Release Lead
Baxter
01.2024 - Current
- Lead the final product release program for Alliston plant, Ensuring Compliance to regulations and optimal performance. Responsible for optimization of batch release program.
- Supported review and quality approval processes for validation protocols, change controls, and non-conformances, ensuring compliance with regulatory standards and organizational policies
- Leads and participates in continuous improvement projects with objective of achieving quality, reliability, and cost improvement goals
- Assist in internal and external audits related to non-conformance management, providing necessary documentation and evidence of compliance
- Coordinated cross-functional teams, ensuring alignment from R&D to regulatory affairs and maintaining project timelines
- Managed end-to-end product delivery, consistently meeting milestones on time and within budget
- Proactively identified and mitigated risks to ensure quality & regulatory compliance and minimize delays
- Provided strategic insights aligned with business goals, fostering innovation for successful product launches
Quality ASSOCIATE I
Baxter
02.2021 - 12.2023
- Provides immediate directions for potential quality issues on the shop floor including first assessment of potential deviations and initial determination of product impact, containment and immediate corrective actions utilizing track wise system
- Support initiation/investigation and approvals of non-conformance events in the track wise system
- Leading continuous improvements, approvals of investigation, CAPA and change controls in timely manner
- Review batch records, Audit trails and other electronic data sources required to support batch releases
- Created/Harmonized/Reviewed Standard Operating Procedures (SOP), Work Instructions (WI) and Guidance document according to GMP and regulatory requirements
Quality Assurance in Process Mfg.
Apotex Inc
10.2018 - 02.2021
- Responsible for execution of quality checks (start-up approval, end of batch tests, AQL inspections and special testing requests (STR)
- Supports the investigative phases related to manufacturing process events, and implementation of corrective and preventive actions (CAPAs)
- Ensure control of WIP materials (quarantine, retention, and disposal areas) to ensure adequate segregation, movement, documentation, and timely follow-up
- Assist in the preparation activities leading up to Regulatory and customer inspection
- Experience reviewing documents for different operations (Granulation, Compression, and Encapsulation
Regulatory Affairs Associate
Eco-Med Pharmaceutical Inc.
11.2016 - 12.2017
- Provided regulatory input in change controls/ deviation management and maintained internal database with quality system activities
- Prepared applications for approval of class 2 medical devices in Canada and international regions
- Coordinated responses to FDA deficiency letters, addressing concerns promptly and professionally while minimizing disruption to ongoing projects.
- Review and approve Labeling material for regulatory compliance and compiled documentation for device Notification, product review and site license renewals
- Effectively performed Post Market Surveillance and reviewed data for cost optimization of marketed products
Executive (Quality Assurance)
Jay formulation Pvt ltd
07.2014 - 11.2015
Hospital Pharmacist
SAL Hospital
03.2014 - 06.2014
Education
Graduate Certificate - Healthcare Management
Canadore College
MississaugaPost Graduate Diploma - Pharmaceutical Regulatory Affairs
Toronto Institute of Pharmaceutical Technology
TorontoPost Graduate advanced Diploma - Clinical Research
Gujarat University
IndiaBachelor of Science - Pharmacy
Rajasthan University of Health Sciences
IndiaSkills
- Audit and inspection Management
- Track wise
- SAP
- LIMS
- CGMP & Regulatory Compliance
- Product Life Cycle management
- Clinical Pharmacovigilance
- Risk Management
- Drug & Clinical development process
- Deviations/change control/Quality Incident
- Regulatory Submissions
- Continuous improvements
- Project Management
- Rational Persuasion
Projects/Accomplishments
Project Manager:
- Pilot plant scale up for Hydromorphone 'Mini tab in Capsules' formulation.
- Product release and control optimization.
- Standardization of rework/Reinspection process.
- DEHP to DEHT Material change, Regulatory commitment.
- Sanitization Time Reduction for RO and Distilled water Loop Systems.
Timeline
Senior Quality Associate II, Batch Release Lead
Baxter
01.2024 - Current
Quality ASSOCIATE I
Baxter
02.2021 - 12.2023
Quality Assurance in Process Mfg.
Apotex Inc
10.2018 - 02.2021
Regulatory Affairs Associate
Eco-Med Pharmaceutical Inc.
11.2016 - 12.2017
Executive (Quality Assurance)
Jay formulation Pvt ltd
07.2014 - 11.2015
Hospital Pharmacist
SAL Hospital
03.2014 - 06.2014
Graduate Certificate - Healthcare Management
Canadore College
Post Graduate Diploma - Pharmaceutical Regulatory Affairs
Toronto Institute of Pharmaceutical Technology
Post Graduate advanced Diploma - Clinical Research
Gujarat University
Bachelor of Science - Pharmacy
Rajasthan University of Health Sciences
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