Executive - Quality Assurance

Job Summary:

This position will be responsible for ensuring that all products and processes comply with regulatory standards and internal quality policies. Also responsible for managing documentation, handling deviations and change control, overseeing validation processes, ensuring data integrity, driving continuous improvement, managing Corrective and Preventive Actions (CAPA), and conducting internal audits.

Key Responsibilities:

Documentation Management

• Act as author, maintaining and managing quality documentation in digital B. Braun Document and collaboration system.
• Maintain and update quality assurance documentation, including Standard Operating Procedures (SOPs) and forms.
  
  

• Identify, document, and investigate deviations from standard processes.
• Perform root cause analysis and implement corrective actions to prevent recurrence.
• Ensure timely closure of deviation reports and maintain records for audit purposes.
• Involve in change control activities and co-ordinate from QM perspective.
  
  

• Develop and execute validation protocols for equipment, processes, and software.
• Ensure validation activities comply with regulatory standards and industry best practices.
• Maintain validation documentation and ensure it is readily available for audits.
• Responsible for Sterilization validation.
  
  

• Ensure the accuracy, consistency, and reliability of data throughout the manufacturing process.
• Implement and monitor data integrity policies and procedures.
• Conduct regular audits to verify data integrity and address any discrepancies.
  
  

• Manage the CAPA process, including the identification, investigation, and resolution of quality issues.
• Develop and implement CAPA plans to address root causes and prevent recurrence.
• Track and report on the status of CAPA activities to ensure timely completion in digital B.TraQS system.
  
  

• Involve and co-ordinate internal audits to assess compliance with quality standards and regulatory requirements.
• Assist in preparing audit reports and communicate findings to relevant stakeholders.
• Follow up on audit findings to ensure corrective actions are implemented and effective.
  
  

• Education: Bachelors degree in a relevant field (e.g., Bio Engineering, Life Sciences, Engineering, Quality Management).
• Experience: Minimum of 5 years of experience in quality relevant in manufacturing , preferably in the medical device or pharmaceutical industry.
• Certifications: Preferrable to have internal auditor certification in ISO 13485 & awareness on Indian Medical Device Rule and EU Medical Device Regulations.
• Knowledge: Preferrable to have knowledge in standards, including ISO 13485, CE marking, EU MDR 2017/745 and Indian Medical Device Rules & regulations.
• Skills: Excellent document management and system handling skills. Strong communication and interpersonal skills.
• Attention to Detail: High level of accuracy and attention to detail in all tasks.