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

B-Pharmacy


M-Pharmacy



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.