18/02 Vnagji
Team Lead at Kanary Staffing Pvt. Ltd.

Views:249 Applications:6 Rec. Actions:Recruiter Actions:0

Research Scientist - Pharma (6-9 yrs)

Uttarakhand Job Code: 5742

 Research Scientist - USFDA


One of our leading Pharma based Clients in Roorkee is looking for Research Scientists who has good work experience in US Drug Regulatory Affairs.

Designation: Research Scientist

Experience: 5 - 8 Years

Location: Roorkee, Uttarakhand

Job Responsibilities:

- To provide documentation support to corporate regulatory team for timely submission of dossiers / amendments / supplements by providing quality documents.

- To review the plant documents like specifications, BMRs, BPRs, Stability protocols, hold time protocols, validation protocols and reports etc.

- To review the quality documents like Deviations, APQRs, Change Controls and incident reports raised during the manufacturing operation.

- To ensure the regulatory compliance is maintained in the plant in-line with the filed dossiers and post approval commitments.

- Apply the manufacturing licenses, GMP certificate, FSC and COPPs for drug products from the state FDA (Uttarakhand) 

- To review of code to code material transfer with in plant.

- To review the document intended to regulatory submission like analytical documents, stability data, BMR and BPR etc.

- In absence, designated deputy shall assume the responsibility.

- To perform additional responsibility assigned by HOD.

This job opening was posted long time back. It may not be active. Nor was it removed by the recruiter. Please use your discretion.

Add a note
Something suspicious? Report this job posting.