Job Description

Department Details

Role Summary

To plan day to day shift activities in coordination with the superior to carry out production activity in order to achieve production targets.
To ensure that all production activities are carried out in compliance with the cGMP requirements by strictly adhering to the standard operating procedures and good documentation practices.
Ensures all team members strictly comply with cGMP procedures and immediately calls attention and corrects any member deviating procedures.
To record and maintain daily reports.
Responsible for reporting any kind of illness or any abnormal health condition to immediate supervisors so that appropriate action can be taken.
Adherence to safety, health, hygiene and environmental measures.
Follow dedicated procedures to enter Drug Product building as per Procedure.
Follow dedicated procedures to enter Cleanroom area of Drug Product building as per Procedure.
Follow dedicated behaviour and hygiene as required in cleanroom area as per procedures.
Strictly implements line clearance procedure as per Procedure. Does not start line unless it is cleared to operate. Escalates any issue immediately to superior.
To carry out and ensure that the following activities are performed as per Standard Operating Procedures below:
a) Monitoring of cleaning activities with correct disinfectant and frequency.
b) Monitoring and recording area differential pressure, temperature and relative humidity.

Key Responsibilities

Identification and raising deviation, change control and compiling other related documents in coordination with QA.
To coordinate with other departments such as QA, QC, Warehouse, EM and IA to achieve day to day production targets.
Performs as per agreed with the job holder that may enhance skills acquisition and / or enrich career development and support attainment of site goal and objectives
Carry out related tasks as maybe assigned, provided sufficient training and proper orientation are given (As agreed with immediate superior)
Contributes in handling the problems related to Filling and Autoclave in co-ordination with EM and IA.
Raising Maintenance Requisition Form regarding problems and handling the concerns in a correct and proper manner.

Educational Qualifications

Required Education Qualification: BA/ B.Com/ B.Sc
Required Experience: 1 - 3 years

Biocon