Natco Pharma Recruiting Senior Executive / Assistant Manager – DQA (API R&D)

Natco Pharma Limited is a vertically integrated and R&D focused pharmaceutical company engaged in developing, manufacturing and marketing of finished dosage formulations (FDF) and active pharmaceutical ingredients (APIs). Our focus is primarily on niche therapeutic areas and complex products. We market and distribute our products in over 40 countries. We sell our FDF products in the United States, India, Europe and the rest of the world (RoW). We also operate in certain key geographies through our subsidiaries’ manufacture API products which are primarily used for captive consumption in our FDF products and are also sold to customers for various international markets such as Brazil, Europe and USA. In the API segment, we have capabilities to develop and manufacture products with multi-step synthesis, semi synthetic fusion technologies, high-potency APIs and peptides

  • Vacancy details:
  • Department:  Senior Executive / Assistant Manager – DQA (API R&D)
  • Qualification:M. Sc(Chemistry)
  • Experience Required: 7 – 10 years
  • Salary:₹Not Disclosed

Job Description: Greeting from Natco Pharma…!!!!

  • Important Details :
  • Location: Ahmedabad( Moraiya )
  • Post of date: 22/06/2024
  • Selection Process: The selection will be on the basis of Interview.
  • Mode of Interview: Face To Face Interview
  • Interview Rounds of Interview: HR

Job description

We are looking Sr Executive / Assistant Manager for DQA (API R&D) for our Research Center located at Hyderabad.

Department: Development Quality Assurance (API R&D)

Position: Senior Executive / Asst Manager

Experience: 7 to 12 Years

Qualification: M. Sc(Chemistry)

Work Location: Natco Research Center – Sanathnagar

Preferably from API R&D – DQA (worked in R&D then moved to DQA)

Job Responsibilities:

  • Responsible for review of following CRD documents for accuracy and adequacy.

1. Review of Process development reports.

2. Review of Process technology transfer document.

3. Review of vendor Compliance data for raw material vendors.

4. Review of vendor performance report/communication for the vendor qualification process.

  • Review of Extended Investigation Protocols & Reports.
  • Preparation and review of DQA SOPs/GLS
  • Review of SOPs & GLs belongs to the Cross-functional department.
  • Responsible for product review meetings (Specification settings, technology transfer, third-party issues, process validation protocol, and reports review related to third-party sites)
  • Responsible for review of quality management system activities in DQA
  • Responsible to establish formalized and scheduled training programs for all employees in the areas of DQA.
  • Internal audit of the cross-functional departments to ensure that the laboratory operations comply with GLP.
  • Maintenance of quality agreements with vendors & service providers
  • Ensuring the availability of Site master layouts and drawings and keep updating in coordination with maintenance.
  • Review of Instrument / Equipment Qualification and calibration reports.
  • Issuance of Books and formats
  • Handling of External Samples and Documents.
  • Evaluating business outputs and operational processes to ensure that everything adheres to the quality standards and business regulations
  • Maintaining the hand-to-hand working relationship with the SCM team and vendors.
  • Coordination with corporate quality assurance for the technical visits to the customer sites.

Interested & Relevant experienced candidates can share their updated CV’s at [email protected]