Key Responsibilities:

• Review of CRD documents for accuracy and adequacy.
• Review of Process Development Reports and Process Technology Transfer Documents.
• Review Vendor Compliance Data for raw material vendors.
• Evaluate Vendor Performance Reports/Communications for the Vendor Qualification Process.
• Review Extended Investigation Protocols & Reports.
• Prepare and review DQA SOPs/GLS.
• Review SOPs & GLs from Cross-functional Departments.
• Conduct Product Review Meetings (Specification settings, technology transfer, third-party issues, process validation protocol, and reports review related to third-party sites).
• Oversee Quality Management System Activities in DQA.
• Establish and maintain formalized and scheduled training programs for all employees in DQA.
• Perform internal audits of cross-functional departments to ensure GLP compliance.
• Maintain quality agreements with vendors & service providers.
• Ensure the availability and updating of Site Master Layouts and Drawings in coordination with maintenance.
• Review Instrument/Equipment Qualification and Calibration Reports.
• Issue Books and Formats.
• Handle External Samples and Documents.
• Evaluate business outputs and operational processes to ensure adherence to quality standards and regulations.
• Maintain a strong working relationship with the SCM team and vendors.
• Coordinate with corporate quality assurance for technical visits to customer sites.

Preferred Background:

• Candidates with experience in API R&D and Development Quality Assurance.
• Previous experience transitioning from R&D to DQA roles is highly desirable.

How to Apply:

Interested and relevant experienced candidates are encouraged to share their updated CVs at Jaganmohan.p@natcopharma.co.in.