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About Company

We are seeking a highly skilled and experienced Senior Executive / Assistant Manager for our DQA (API R&D) department. The ideal candidate will have a strong background in API R&D with a focus on quality assurance and process development. This role is based at our Research Center in Hyderabad, with additional responsibilities at our Ahmedabad location.

Position Name :

Sr Executive / Assistant Manager – DQA (API R&D)

Organization :

Natco Pharma

Qualification:

M. Sc(Chemistry)

Experience:

7 – 10 years

Salary:

₹2.00 - ₹5.4 lac (Approx)

Location:

Ahmedabad( Moraiya )

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.