VISHAL KHUNT
Markham
Summary
Experienced in the API pharmaceutical Industry, I possess strong technical knowledge and expertise. I excel in pharmaceutical compliance and have a track record of leading successful projects. By staying up to date with the regulations, I ensure companies maintain USFDA compliance. With exceptional trouble shooting skills, I deliver timely results. Seeking a role where I can leverage my leadership and project management abilities to drive growth in the pharmaceutical or food sector.
Overview
7
7
years of professional experience
Work History
Supervisor (Executive)
Apicore Pharmaceutical Pvt. Ltd
07.2018 - 08.2021
- Co-ordinated with the manufacturing department in controlling their process and products at every stage of manufacturing to meet the established specification through testing, auditing, and reporting.
- Effectively organized and supervised all operations within the Quality Assurance and Manufacturing department, ensuring the highest standard of quality for all company manufactured medicinal products.
Officer
Glenmark Pharmaceuticals Ltd.
09.2017 - 06.2018
- Managed the handling of critical products and supervised key process steps, including Friedel Craft acylation and quenching reactions, while adhering to Good Manufacturing Practices (GMP).
- Closely monitored production activities according to pre-planning, ensuring effective handling deviations, change control, and CAPA (Corrective and Preventive Actions)
- Conducted regular audits of the manufacturing processes, controls, and related areas to ensure compliance with Good Manufacturing Practices (GMP)
Officer
Sun Pharmaceutical Industries Ltd
01.2016 - 08.2017
- Demonstrated successful compliance with USFDA and EDQM audits during my tenure at Sun Pharmaceuticals (January 2017) and Glenmark Pharmaceuticals (March 2018), respectively
- Initiated and coordinated training programs aimed at enhancing technical and administrative skills of all employees, ensuring continuous compliance with cGMP regulations. Collaborated with plant and quality head to design and organize these training initiatives
Officer
Amoli Organics Pvt. Ltd
07.2014 - 01.2016
- Studied and proposed Ideas to improve process efficiency and effective utilization of resources
- Addressed real time onsite issues and devised result-oriented solutions within time and cost-effective factors
- Maintained Drug Manufacturing area as per USFDA Guidelines
- Filled up and reviewed pharmaceutical documents as per good documentation practices
- Operated various pharmaceutical equipment's such as Reactors, Centrifuge, Dryers, and PLC based plant
- Effectively managed manpower allocation based on identified needs in different areas
Education
Master of Science - Regulatory Affairs For Drugs, Biologics, Devices
Northeastern University
Toronto, ON, Canada07.2023
Master of Science - Pharmaceutical Chemistry
Sardar Patel University
Anand, Gujarat, India04.2014
Bachelor of Science - Biochemistry
Sardar Patel University
Anand, Gujarat, India04.2012
Skills
- Exceptional communication skills, excellent reporting skills and able to work independently and work well under pressure
- Have excellent organizational skills including time and project management and priority setting for self and others
- CPR Certified, equipped to respond effectively in emergency situations
- Foundational computer skills: G suite, E-mail, Microsoft office 365
Regulatory Affairs Projects and Assignments
- Researched FDA GMP Warning Letters, summarizing noncompliance issues for 3 subparts of GMP (21 CFR 211).
- Conducted risk assessment and mitigation for a potent impurity outside of clinical experience (timelines, supply, NDA, budget).
- Prepared IND amendment for FDA approval of saline supply from an international manufacturer.
- Created mock CAPA form considering QSR, Risk Analysis, and Compliance Management.
- Completed final project on Medical Device Regulatory Strategy (UK).
Sports, Music, Travel
Engaging in sports boosts my self-esteem, while music brings me a sense of tranquility. Additionally, I have an unwavering passion for traveling and immersing myself in the beauty of nature.
Timeline
Supervisor (Executive)
Apicore Pharmaceutical Pvt. Ltd
07.2018 - 08.2021
Officer
Glenmark Pharmaceuticals Ltd.
09.2017 - 06.2018
Officer
Sun Pharmaceutical Industries Ltd
01.2016 - 08.2017
Officer
Amoli Organics Pvt. Ltd
07.2014 - 01.2016
Master of Science - Regulatory Affairs For Drugs, Biologics, Devices
Northeastern University
Master of Science - Pharmaceutical Chemistry
Sardar Patel University
Bachelor of Science - Biochemistry
Sardar Patel University
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