Quality Assurance Executive - RA

Job Summary:

Ensure manufacturing process complies with standards.

• Establish and update quality plans.
• Establish and update quality assurance procedures and specifications.
• Maintain and update quality assurance records.
• Data analysis and continual improvement

Complaints handling

• Lead or participate in the investigation root cause determination of internal and external complaints.
• Initiate and implement corrective and preventive action.
• Document the complaint investigation, CAPA and closure of complaints.

Direct and drive quality objectives.

• Co-ordinate with production and R&D to identify realistic and impactful quality objectives

and focal for each objective.

• Monitor the progress of each objective and aid focals to achieve the objectives.
• Document and update the objectives

Internal quality audit and External audit

• Ensure availability of documents at the time of audit.
• Co-ordinate with regulatory team and fulfill the audit requirements.
• Ensure timely closure of audit findings.
• Prepare DMR for new products.
• Co-ordinate with R&D team in preparation of documents such as quality plan, SOPs, Risk

analysis, MDD documents and technical specification etc.

Experience:

1 to years of experience in Medical device or any pharmaceutical company.