Executive - Quality Assurance

Job Summary:

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.
  

Deviation Management and Change Control

• 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.
  

Validation

• 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.
  

Data Integrity

• 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.
  

Corrective and Preventive Actions (CAPA)

• 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.
  

Internal Audits:

• 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.
  

Job Requirements:

• Education: Bachelor's 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.