JOB DESCRIPTION

1. Preparation and signing authority for:

• Commercial product / stability batches / exhibit batches / characterization batches– Master Batch Manufacturing Record.

• Risk Assessment, process Validation protocol, incident and investigation report, action, compliance, and closure.

• CAPA plans and closure.

• Protocols & reports.

• Internal Quality Audit/ Regulatory Quality Audit Compliance and closure.

• Change control, Standard Operating Procedure, Planned Modification.

2. Responsible for training activity of staff members, technicians and contract workers of Aerosol and nasal spray department as a Department training coordinator (DTC). As a part of DTC, below activities shall be performed as -

• Preparation and updating of Master Training Needs Matrix of their respective department for different job role(s) in consultation with LTC and Depar...