Senior Executive, QMS

Description

• Independently conduct and prepare investigation reports for Product Quality Complaints, Unplanned Deviations, OOS, OOT, and OOAL events, ensuring timely closure and regulatory compliance.
• Perform root cause analysis using appropriate tools (5-Why, Fishbone, Risk Assessment, etc.) and recommend effective corrective and preventive actions (CAPA).
• Initiate, review, track, and verify CAPA implementation and effectiveness within established timelines.
• Review and coordinate Change Controls related to processes, equipment, facilities, systems, materials, and documentation, including quality and regulatory impact assessments.
• Analyze and prepare annual trend reports for Unplanned Deviations, Complaints, CAPAs, OOS, OOT, and OOAL events to identify recurring issues and drive continuous improvement.
• Prepare Quality Metrics, Management Review reports, and periodic trend analyses for site leadership.
• Maintain QMS records in compliance with cGMP, Data Integrity (ALCOA+), and company procedures.
• Support internal audits, customer audits, and regulatory inspections.
• Assist in the development, review, and revision of SOPs and other quality system documents.
• Collaborate with Manufacturing, Quality Control, Engineering, Validation, and other cross-functional teams to resolve quality issues.
• Support inspection readiness initiatives and promote continuous improvement of Quality Management Systems.
• Ensure all activities are performed in compliance with applicable cGMP, FDA, ICH, company policies, and Health & Safety requirements.

Additional Skills

• Strong understanding of QMS principles and compliance.
• Knowledge of GMP, cGMP, GLP, GDP, and regulatory requirements from agencies such as the U.S. Food and Drug Administration, European Medicines Agency, and World Health Organization.
• Strong attention to detail to identify documentation errors and ensure data integrity.
• Strong written and verbal communication skills for preparing reports, leading discussions, and driving quality initiatives.

Education

• B. Pharm B. Pharm - Required
• M. Pharm M. Pharm - Preferred

Experience

• 5 years or more in 5 - 8 Years

Specialized Knowledge

Licenses