Co-ordination with F&D, AMD, QA, QC & Production department for technical data required for registration.(US)
Review of master documents such as BMR, BPR and other analytical related documents required for submission.
Preparation and submission of DMF to Customers and regulatory Authorities
.Review of Change Controls and Deviations.
Review of BA/BE study related data such as ICF, CRF, Validation Protocols, Validation Reports study protocols, study reports etc.
Review of SOP, STP, MVP, MVR, and BSP related to study.
Conduct internal audits to comply with quality standards.
Hands on experience of working on HPLC, GC and other instrumental techniques.
Desired Candidate Profile
Candidates should be a Male person.
Should be into Formulation
dealing into US Market.