Title:  Manager - 1

Role: Manager 1/Manager 2 – Production QMS

Industry Preference: Parenteral Production

Roles and Responsibilities:

Responsible for handling of QMS related activities through QMS software.

- Handling of Incident and cross functional investigation report

- Handling of change control

- Handling of corrective and preventive action

- Handling of interim report

- Initiation of extension

Handling of manufacturing compliance.

To review documents related to clean area & Aseptic area.

To ensure timely submission of response to QA observation, Internal and external audit findings.

SOP preparation / revision and review including other activities through EDMS.

To prepare and review Batch Manufacturing Record.

To prepare and review process validation protocol and other protocol as per QMP.

To monitor training of new employees as per Departmental Training Manual.

To ensure compliance status as per current procedure for departmental activities

Reporting of day to day activities to the superiors with specific highlights to important issues and development activities.

To ensure that cGMP practices is followed in department.

To execute training coordinator related activities in LMS.

To monitor the facility related observation and to coordinate with other department for fulfillment.

SOP gap assessment and implementation against global documents.

To sign departmental documents in absence of Department Head.

To implement system / changes that are required for updation of the department.

To execute any activities assigned by management and senior.

Job Location: Baska