
Dynamic Quality Assurance Specialist with a proven track record at Emzor Pharmaceutical Industries, Results-driven Quality Assurance professional with experience in ensuring compliance with regulatory standards, managing audits, and promoting continuous improvement in the pharmaceutical industry. Proven track record of implementing quality management systems, leading audit teams, and driving quality initiatives. Skilled in data analysis, documentation, process validation, and product quality review.
Professional Experience
*Quality Management and Compliance
- Ensured compliance with cGMP, QMS, HACCP, and CFIA programs, maintaining quality certifications.
- Developed and implemented quality initiatives, promoting a culture of quality and safety.
- Managed and controlled document management systems, ensuring accuracy and accessibility.
*Audit Responsibilities*:
- Coordinated and conducted internal audits (Level 1 audit), preparing audit reports and following up on CAPA and audit closure.
- Led the plan-do-check-act (PDCA) process for the site quality management system (ISO 9001:2015).
- Planned and managed internal audit programs, conducting process approach audits effectively
*Risk, Validation & Compliance*:
- Coordinated validation activities (Process Validation) for products, preparing validation reports.
- Ensured compliance with validation programs and plans.
*Data Analysis and Reporting*:
- Prepared Annual Product Quality Reviews, trend analysis, and reports on non-conforming products.
- Conducted data analysis, ensuring zero percent error.
- Provided quality reports, ensuring timeliness and accuracy.
*Training and Development*:
- Assisted in coordination of training functions for operation units, facilitating selected trainings.
- Developed and delivered training programs, enhancing quality awareness and compliance.
*Key Achievements*:
- Successfully implemented quality management systems, ensuring compliance with regulatory standards.
- Led quality initiatives, promoting a culture of quality and safety.
- Developed and delivered training programs, enhancing quality awareness and compliance.
Quality management systems
- Audit management
- Risk analysis and CAPA
- Validation and compliance
- Document management
- Quality training and onboarding
- Data analysis and reporting
- SPC methodologies
- CTQ & CCP monitoring, analysis, control, and management