Bhakti Hirani
Cambridge,ON
Summary
Dedicated and results-driven Quality Control Executive with 3.4 years of experience in the Medical Device Manufacturing industry. Aiming to leverage expertise in regulatory compliance, process improvement, and team leadership to contribute effectively to a dynamic organization's success.
Overview
5
5
years of professional experience
Work History
Quality Control Executive
OmniBRx Biotechnologies pvt. ltd.
12.2022 - 04.2023
- Trained personnel on laboratory functions and conducted team-based laboratory tests.
- Developed and executed validation plans, while also maintaining trend data of test results.
- Prepared standard protocols for testing methods and generated environmental impact reports.
Quality Control Executive
MediTech Devices pvt. ltd.
09.2021 - 12.2022
- Established quality procedures and standards, supervised inspectors and technicians.
- Troubleshot product issues, trained personnel, and demonstrated laboratory tests.
- Managed diagnostic test results and conducted chemical and biological tests on various samples.
Quality Control Officer
Advanced Medtech Solutions pvt. ltd.
09.2020 - 09.2022
- Conducted product inspections and recommended process improvements to meet quality standards.
- Trained new employees, conducted inspections, and used specialized tools for precise measurements.
- Documented non-conformities, performed root cause analysis, and maintained safety protocols.
Quality Control Associate
Envision Scientific pvt. ltd.
06.2019 - 08.2020
- Maintained policy, procedures, work instructions and projects for quality and continuous improvement agendas.
- Analyzed issues and recommended corrective actions to improve final results.
- Conducted tests on product samples and recorded results.
- Received and inspected raw materials, in process material and finished goods.
- Maintained lab cleanliness and safety standards.
- Calibrated, validated or maintained laboratory equipment.
- Participated in technical trainings and workshops to improve skills set and boost overall knowledge.
Quality Control Trainee
Cadila Healthcare Limited
05.2018 - 05.2018
- Complied with company and regulatory requirements related to safety and quality.
- Monitored and upheld safe operating procedures and clean area mandates to meet regulatory requirements.
- Monitored overall laboratory testing methods and learned established item specifications and standard protocols.
Education
Post Graduation Diploma - Regulatory Affairs
Conestoga College Institute of Technology And Advanced Learning
Kitchener, ON12.2023
Master of Science - Microbiology
Sardar Patel University
Gujarat, India03.2019
Bachelor of Science - Microbiology
Sardar Patel University
Gujarat, India03.2017
Skills
- Regulatory Compliance
- Work Planning and Prioritization
- Project Management
- Written and Verbal Communication
- Operation Monitoring
- Attention to Detail
- Process Analysis
- Quality Standards Determination
- Internal Audits
- Quality Systems
- Risk Analysis and Mitigation
- Analytical Problem-Solving
- Medical Device Inspections
- Product Testing and Development
- Final Product Approvals
- Process Documentation and Improvement
- Test Result Interpretation
- Specification Review
- Quality Control
- Product complaint root cause analysis and Preventive Actions
- CAPA Management
- Process Capability Analysis
- Auditing Techniques
Publication
Performed research work on Mastitis infected mammalians. Published research findings and statical data in Lamberts Academic Publishing "Insight into the Microbial Diversity of Mastitis Infected Mammalians"
Software Skills
- SAP
- Caliber DMS
- Data Note
- LIMS
- ERP
Timeline
Quality Control Executive
OmniBRx Biotechnologies pvt. ltd.
12.2022 - 04.2023
Quality Control Executive
MediTech Devices pvt. ltd.
09.2021 - 12.2022
Quality Control Officer
Advanced Medtech Solutions pvt. ltd.
09.2020 - 09.2022
Quality Control Associate
Envision Scientific pvt. ltd.
06.2019 - 08.2020
Quality Control Trainee
Cadila Healthcare Limited
05.2018 - 05.2018
Post Graduation Diploma - Regulatory Affairs
Conestoga College Institute of Technology And Advanced Learning
Master of Science - Microbiology
Sardar Patel University
Bachelor of Science - Microbiology
Sardar Patel University
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