MITUL PATEL
Brampton,ON
Summary
Dedicated professional skillful in quality management system for drug and clinical products. Carrying a knowledge of pharmaceutical regulations (e.g. Health Canada, CDSCO, MDSAP, FDA) along with GMP & GDP. Ready to contribute to drive continuous improvement and uphold the highest quality standards in a challenging technical role.
Overview
7
7
years of professional experience
1
1
Certification
Work History
QC/QA Laboratory Technician
Virox Technologies
09.2020 - Current
- During batch record review, Ensure technical documentation completeness, error correction, and analytical data accuracy
- Granting approval and release of quality records, critical clinical products, batch records and master labels
- Conduct and maintain quality procedures such as risk assessment review, non-conformance, deviation and CAPA
- Assist manager in developing new SOPs and other controlled documents
- Perform regular audits to verify compliance to ISO 9001, ISO 13485 as well as to Occupational health and safety standards
- Help in regulatory audits such as Health Canada and FDA along with some internal and corporate audits
- Regularly deal with customer complaints and participate in investigations as well as CAPA system.
QA Associate
Torrent Pharmaceutical Limited
01.2017 - 09.2018
- Co-ordinate with manufacturing department in accomplishing established procedures and compliance with regulatory requirements
- Review and maintain all records such as batch/release, product and component rejection, labels, and raw materials results, stability testing
- Assist in change control system, non-conformance investigations (if OOS occurs), as per SOP
- Conduct regular compliance tasks such as annual batch record review, stability assessment, and annual product quality review (APQR).
- Accompanying external and corporate audits along with regulatory inspections (e.g CDSCO, FDA)
Education
Some College (No Degree) - Chemistry
Sheridan College
Brampton, ONBachelor of Science - Chemistry
Veer Narmad South Gujarat University
Surat, Gujarat04.2018
Skills
- Proficient with MSWord, Excel, Outlook, LIMS, QES, Entropy, and GP Dynamics
- Fast learner, reliable, accountable, Self Starter
- Strong organizational and time management skills
- Proven problem-solving and troubleshooting skills
Accomplishments
- HSE Department member: As an Occupational Health and Safety member, identify workplace hazards during facility inspections and perform root cause analysis, safety compliance, prepare corrective action report,
- Development of LIMs Traceability System.
- Optimization of Standard Operating Procedures and Control documents.
Certification
- Pharmaceutical Industry Drug Regulatory Affairs, Udemy - April 2023
Regulatory Knowledge
- REACH, RoHS, WEEE, MDSAP, Safety Data Sheet
- ISO 9001, ISO 13485
Timeline
QC/QA Laboratory Technician
Virox Technologies
09.2020 - Current
QA Associate
Torrent Pharmaceutical Limited
01.2017 - 09.2018
Some College (No Degree) - Chemistry
Sheridan College
Bachelor of Science - Chemistry
Veer Narmad South Gujarat University
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