Kanary Staffing is specialised in providing services for multiple facets of HR like Permanent Staffing & Contract Staffing, Pay-rolling & HR Consulting. It aims to grow its footprints in Industries like IT, ITES, PHARMA, ENGINEERING & MANUFACTURING.
Post : Research Scientist - USFDA
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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.
Additional Information
Qualification : M.Pharm
Experience: 2 – 6 Years
Location : Roorkee, Uttarakhand
Industry Type : Pharma
Functional Area : R&D
End Date : 10th March, 2019
Interested Candidates, kindly drop your CVs to jobs@kanarystaffing.com
Posted by
Vnagji G
Kanary Staffing Pvt. Ltd
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