ASSISTANT MANAGER

Department Details

Role Summary

• Requisition and receiving BMR (Additional Page) and batch related execution checklists. • Receiving document number / effective date for technical documents, Protocols, and reports. • Preparation, issuance and archival of logbooks • Preparation and revision of technical documents, Protocols, and reports. • Receiving technical documents, Protocols, reports and SOP copies and IOC • Entering of all the logs and documents related to visual inspection area. • Reviewing of all completed logbook and arranging them in document storage. • Responsible for the verifying all executed document BMR Initiation and Review of Change control, CAPA, Event • Responsible for tracking (CFT review, approval, and completion / closure) of Change control, CAPA, Event. • Initiation of extension • Handling assigned Change control, CAPA, Event for closure • Handling of change control, deviations, CAPA in coordination with QA department. • Involving in the Investigate and closure of deviation. • To Adhere to the Good hygiene practices and reporting to illness and other unhygienic incidents Identification of Personnel • Adherence to Good documentation practices. • Verification of Documents, annexures for its completeness and correctness after completion of activity.

Key Responsibilities

• Requisition and receiving BMR (Additional Page) and batch related execution checklists. • Receiving document number / effective date for technical documents, Protocols, and reports. • Preparation, issuance and archival of logbooks • Preparation and revision of technical documents, Protocols, and reports. • Receiving technical documents, Protocols, reports and SOP copies and IOC • Entering of all the logs and documents related to visual inspection area. • Reviewing of all completed logbook and arranging them in document storage. • Responsible for the verifying all executed document BMR Initiation and Review of Change control, CAPA, Event • Responsible for tracking (CFT review, approval, and completion / closure) of Change control, CAPA, Event. • Initiation of extension • Handling assigned Change control, CAPA, Event for closure • Handling of change control, deviations, CAPA in coordination with QA department. • Involving in the Investigate and closure of deviation. • To Adhere to the Good hygiene practices and reporting to illness and other unhygienic incidents Identification of Personnel • Adherence to Good documentation practices. • Verification of Documents, annexures for its completeness and correctness after completion of activity.

Educational Qualifications

Required Education Qualification: B.Sc
Required Experience: 10 - 13 years