Senior Executive / Assistant Manager, QMS - Market Complaints

You will be responsible for handling market complaint investigations and closures, coordinating with cross-functional teams for data collection and assessment, and performing thorough investigations to identify root causes of complaints. You will evaluate batch manufacturing and testing records, deviations, OOS/OOT results, change controls, and other relevant documents. It will be your duty to prepare comprehensive investigation reports within defined timelines, ensuring scientific justification for conclusions. You will also recommend and track the implementation of effective CAPA to prevent recurrence of similar issues and communicate investigation outcomes to relevant stakeholders and regulatory bodies as required. Supporting trending analysis and periodic review of complaint data to identify recurring issues and improvement opportunities will be part of your role. You will also ensure compliance with global regulatory expectations and internal quality policies, identifying and recommending effective Corrective and Preventive Actions (CAPA) based on investigation outcomes. Coordinating with relevant departments to ensure timely CAPA implementation and verification of effectiveness, monitoring CAPA status, ensuring closure within defined timelines, and participating in CAPA effectiveness reviews and periodic trend analysis to identify recurring issues and continuous improvement areas will be essential. - Responsible for handling market complaint investigations and closure - Coordinate with cross-functional teams for data collection and assessment - Perform thorough investigations to identify the root cause(s) of complaints - 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 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 You should possess advanced analytical and problem-solving skills, the ability to manage multiple investigations and CAPAs, advanced knowledge of cGMP, GDP, ICH Q10, global regulatory compliance, automated QMS platforms, root cause analysis, and investigation, as well as data integrity (ALCOA+). Qualifications: - B-Pharmacy - M-Pharmacy Amneal is an equal opportunity employer that values diversity and inclusion. The Human Resources team partners with all aspects of the organization, providing high-level input at a strategic level into key business decisions, ensuring compliance with legal requirements and best practice employment policies and procedures, supporting all areas of the organization to meet their objectives through the implementation of effective employment practices, providing expert advice on workforce management, and ensuring the organization is equipped to deal with developments impacting employment matters.,