Senior Executive / Assistant Manager, QMS - Market Complaints

Job Responsibilities

• Responsible for handling of market complaint investigations and closure.
• Coordinate with cross-functional teams (Production, QC, Packaging, Regulatory Affairs, etc.) for data collection and assessment.
• Perform thorough investigations to identify the root cause(s) of complaints (e.g., product quality, packaging, labeling, or distribution issues).
• Evaluate batch manufacturing and testing records, deviations, OOS/OOT results, change controls, and other relevant documents.
• Prepare comprehensive investigation reports within defined timelines and ensure scientific justification for conclusions.
• Recommend and track implementation of effective CAPA to prevent recurrence of similar issues.
• Communicate investigation outcomes to relevant stakeholders and regulatory bodies as required.
• Support trending analysis and periodic review of complaint data to identify recurring issues and improvement opportunities.
• Ensure compliance with global regulatory expectations (e.g., USFDA, EMA, MHRA, WHO) and internal quality policies.
• Identify and recommend effective Corrective and Preventive Actions (CAPA) based on investigation outcomes.
• Coordinate with relevant departments to ensure timely CAPA implementation and verification of effectiveness.
• Monitor CAPA status and ensure closure within defined timelines.
• Participate in CAPA effectiveness reviews and periodic trend analysis to identify recurring issues and continuous improvement areas.

Skills Required

Analytical & problem-solving skills : Advanced

Managing multiple investigations & CAPAs : Advanced

cGMP, GDP & ICH Q10 knowledge : Advanced

Global regulatory compliance knowledge : Advanced

Automated QMS platform proficiency : Advanced

Root cause analysis & investigation : Advanced

Data integrity (ALCOA+) knowledge : Advanced

B-Pharmacy

M-Pharmacy