Job Description
AQA
Preparation of Process Validation Report, Hold Time Study Report, Cleaning verification / validation protocol.
Issuance, Tracking of all QMS records. QMR compilation.
New product checklist initiation verifying document compliance. CV assessment preparation.
Attending regulatory queries, providing response. Document submission to RA.
Stability Annexures compilation.
Issuance of Formats/Specifications & MOA.
Documents archival & control.
Preparation of External Calibration Schedule & Verification of certificates.
Management of Equipment requalification programme.
Ensure compliance of products with registration dossier requirements (Regulatory Compliance”).
Verifying the site compliance with Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).