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.
