QMS Production Associate Job in Ahmedabad at Baxter

Baxter is hiring for the role of QMS Production Associate!

Responsibilities of the Candidate:

• Prepare and review manufacturing investigations related to NCR/OOS/OOT/OOL/market complaints to identify the root cause and implement appropriate CAPA measures
• Conduct risk assessments for associated QMS elements and ensure timely completion
• Define CAPA actions and perform efficiency checks
• Initiate Change Control procedures for any changes and ensure timely execution and closure
• Handle document change requests and impact assessments across cross-functional departments
• Manage QMS activities in Trackwise software
• Prepare and review Standard Operating Procedures (SOPs), exhibits, and standard formats in TcU to ensure compliance with current Good Manufacturing Practice (cGMP) requirements
• Advise the supervisor promptly of any delays in investigations or QMS elements to ensure timely resolution.
• Complete training on assigned SOPs in the BAXU system and ensure team completion
• Supervise all open QMS elements and ensure closure with effective CAPA measures within the defined timeline
• Coordinate with the Training and Development department for initiation, efficiency, and closure of training
• Perform GEMBA as part of investigations, if required
• Attend and implement training related to Quality Management System (QMS) and cGMP
• Ensure data integrity and compliance of all processes and systems through frequent GEMBA
• Prepare for and participate in internal and external cGMP regulatory audits, respond to auditor queries, and maintain audit preparedness in the function
• Report any safety or hazard concerns to the supervisor or relevant individuals in the area
• Perform tasks assigned by management as needed

Requirements:

• Bachelor's degree or equivalent experience in a relevant field (e.g. Manufacturing, Quality Assurance)
• Experience in a manufacturing role, preferably in a regulated industry such as pharmaceuticals or medical devices
• Knowledge of current Good Manufacturing Practice (cGMP) regulations
• Strong attention to detail and ability to identify root causes of issues
• Excellent interpersonal and time management skills
• Ability to effectively communicate and collaborate with cross-functional teams
• Proficiency in using Trackwise software or similar QMS platforms
• Familiarity with change control procedures and document management systems
• Consistent record to efficiently implement CAPA measures and drive continuous improvement
• Ability to perform GEMBA investigations and assess data integrity and compliance
• Experience in preparing for and participating in regulatory audits is a plus
• Strong dedication to safety and adherence to protocols and procedures