Quality Assurance - Executive ( APQR Injectable Plant)

Role & responsibilities :-

• Perform Annual Product Quality Reviews (APQRs) compilation as assigned. 
• Perform complete and correct transactions of the data as per SOP / WIs.

• Ensure that the complete APQR is submitted for review and accepted by the Reviewer and Project Leader QA Product Review/Manager, QA Product Review.
• Co-ordinate with Project Leader(s) QA Product Review / Manager for completion of the projects.
• Compile the APQRs within required timelines to ensure that there is adequate time for approvals.
• Responses to Project Leaders queries for APQR summary reports as required.
• Assist in preparation, review and revision of Standard Operating Procedures (SOPs) as required.
• Ensure that all work is performed in compliance with GMP, SOPs, regulatory requirements and established safety standards.
• Work both independently and as part of intra/inter-departmental teams to ensure that all work is completed in a timely manner to meet both business and quality standards.
• Maintain the tracking system for compilation and review of assigned APQRs.
• Ensure that the annual product reviews are performed in full compliance with current procedures.
• Expert knowledge of International regulatory requirements that apply to Product Reviews.
• Demonstrated cGMP knowledge.
• Excellent technical writing, communication skills and interpersonal skills.