NEENU JOHNY
BRAMPTON,ON
Summary
Highly disciplined and self-motivated Electromechanical Automation Engineering graduate with 6+ years of experience in the pharmaceutical industry. Specializes in GMP environments, quality assurance, and regulatory compliance. Possesses a strong understanding of product quality management, batch record review, deviation investigations, and Health Canada audits. Expertise extends to leading compliance projects, developing regulatory documentation, and ensuring market-ready product releases.
Overview
7
7
years of professional experience
1
1
Certification
Work History
Quality Assurance Technician
Apotex
Etobicoke
10.2019 - Current
- Prioritize and manage compliance projects, ensuring adherence to regulatory standards
- Conduct critical assessments of data and documents to identify gaps relative to regulatory requirements
- Complete client-assigned tasks, including deviation investigations and importer documentation reviews
- Develop comprehensive documentation, including SOPs, protocols, reports, and Annual Product Quality Reviews (APQRs)
- Review master manufacturing and batch records for accuracy and completeness, ensuring timely product lot release
- Assist in hosting Health Canada audits, corporate audits, and self-inspections, ensuring compliance and audit readiness
- Investigate deviations and manage change/CAPA processes to enhance quality and efficiency
- Release products to the market after thorough quality checks and regulatory assessments
- Support regulatory inspections with accurate documentation and process explanations, ensuring industry-standard compliance
- Mentor and train new hires, ensuring successful assessments and adherence to company standards
- Key Achievements:
- Improved production efficiency through effective CAPA management and root cause analysis
- Contributed to the successful implementation of new technologies, enhancing quality and reducing downtime
- Streamlined documentation processes, improving audit preparedness and regulatory compliance
- Analyzed quality and performance data to support operational decision-making.
- Skilled at working independently and collaboratively in a team environment.
Production Technician
Apotex
Etobicoke, ON
08.2017 - 10.2019
- Troubleshot equipment malfunctions quickly to minimize disruptions in production schedules.
- Performed setup of production equipment to establish optimal performance.
- Examined incoming materials and compared to documentation for accuracy and quality
- Trained new team members on equipment operation, safety protocols, and company policies, fostering a skilled workforce.
- Increased workplace safety, conducting thorough hazard assessments and implementing corrective actions.
- Inspected equipment and systems to identify issues, immediately reporting problems to repair technicians.
- Lubricated and cleaned parts to perform routine maintenance on production equipment.
- Participated in root cause analysis investigations for recurring issues, identifying solutions to prevent recurrence.
- Implemented continuous improvement initiatives to optimize production workflows, eliminate waste, and enhance overall performance.
- Trained and supervised production personnel to properly use production equipment and apply best practices.
Education
Electromechanical Engineering Technology - Automation and Robotics
Centennial College
Toronto01.2017
Bachelor's Degree - Electronics and Communication Engineering
Anna University
Tamil Nadu01.2015
Skills
- Quality Assurance & Compliance: Deviation investigations, CAPA/change management, master batch record review, and product lot release
- Regulatory Audits: Health Canada audits, corporate audits, and self-inspections
- Documentation Management: SOP creation, APQRs, protocols, reports, and stability reviews
- Project Management: Compliance project prioritization, milestone tracking, and client task completion
- Technical Expertise: Equipment troubleshooting, process optimization, SAP and LIMS transactions
- Leadership & Collaboration: Mentoring, team training, and communication of project milestones
- Problem Solving: Root cause analysis, continuous improvement, and minimizing production downtime
- Computer Skills: SAP, LIMS, Microsoft Office Suite, Arduino/PIC Microcontroller programming
Certification
- GMP Training (Completed various site-specific training sessions).
- SAP and LIMS Certifications.
- FDA/Health Canada Compliance (audit participation).
Languages
English
Timeline
Quality Assurance Technician
Apotex
10.2019 - Current
Production Technician
Apotex
08.2017 - 10.2019
Electromechanical Engineering Technology - Automation and Robotics
Centennial College
Bachelor's Degree - Electronics and Communication Engineering
Anna University