HomeProductionSenior Manager - Development QA | Walter Bushnell (Apeejay Group) | Gurgaon

Senior Manager – Development QA | Walter Bushnell (Apeejay Group) | Gurgaon


A closely held Company incorporated in 1924 under the Companies Act, 1956 actively engaged in providing Third Party (3PL) solutions for the pharmaceutical sector in India through its unique portfolio of services that encompass marketing to research and development & manufacturing (outside of generic supply chain solutions).

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  The company has a unique distinction of having a nation-wide IT-enabled distribution network through more than 1800 wholesalers/stockists that are serviced through its own 21 branches/depots, geographically spread out to cover the entire Indian subcontinent. The company expects a strong degree of consolidation and migration with regard to the nature and comprehensiveness of 3PL solutions in India and is well equipped in terms of infrastructure, manpower among other resources to take advantage of the same.

Position: Senior Manager – Development Quality Assurance

Division: Marting & Harris

Location: Gurgaon, Haryana, Delhi NCR

Job Description:

  • Development, Review & finalization of SOPs/Guidances for Formulation & analytical functions including equipment’s & instruments.
  • Support development and implementation of appropriate quality systems for IND/NDA/ANDA development activities
  • Perform the review of development documents for IND, NDA, and ANDA submissions, including analytical method development/validation protocols and reports, product development reports, stability protocols, and PV reports
  • Review batch records and associated documentation for release of batches for clinical and/or BA/BE studies
  • Together with Product Development, provide guidance, oversight, and direction to external partners to ensure development activities are performed in a manner compliant with regulatory expectations
  • Perform qualification/due diligence audits of potential development and/or manufacturing partners.

Qualification: B.Pharma, M.Pharma (PG is Compulsory)

Experience: Minimum 10 Years in Pharma Industry, Exposure to both Formulation and Analytical is Desiarable

Salary: Negotiable

Contact Details:

Ms. Rythma Shekhar


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