Senior Executive / Assistant Manager, QMS - Market Complaints

Job Description

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

Qualifications

B-Pharmacy

M-Pharmacy

About Us

Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.

About The Team

The Human Resources team partners with all aspects of the organization, driving success through the effective and innovative management of people for both current and future business needs.

Key Roles That The Human Resources Team Performs

Executive Role: Specialists in all aspects of people management. High-level input at strategic level into all key business decisions.

Audit Role: Ensures all areas of the organization are compliant with legal requirements AND best practice employment policies and procedures.

Facilitator Role: Close partnership to support, advise and extend the ability of all areas of the organization to meet their objectives through implementation of highly effective employment practices in areas such as Talent Acquisition, Learning and Development, Reward systems, Performance Management, Health and Wellbeing.

Consultancy Role: Provide expert advice to the organization and it’s managers on any aspect of workforce management and employee relations and performance.

Service Role: Ensure the organization is fully aware of and is equipped to deal with developments impacting employment matters, such as changes in legislation, changes in the characteristics of the labor market.