Skills

Full description

JOB RESPONSIBILITIES

Working on Unit operations related toupstream processing during Drug Substance (DS)

manufacturing.

GMP documentation related to DS manufacturing like batch records, equipment usage, facility

monitoring.

Preparation of documents like SOPs, MMDs and QMS related documents like change control, deviation, CAPA, risk assessment etc.
Monitoring of manufacturing facility and keep it cGMP compliant
Involvement during regulatory audit preparation
Co-ordination with cross functional teams like QC, QA, Maintenance, Warehouse, Injection etc.
Training and mentoring new joinees
Keep the track for calibration and qualification activities, for example for equipment, weighing scale and standards etc.
Preparation and maintenance of virus stocks and cell banks

JOB RESPONSIBILITIES

Working on Unit operations related toupstream processing during Drug Substance (DS)

manufacturing.

GMP documentation related to DS manufacturing like batch records, equipment usage, facility

monitoring.

Preparation of documents like SOPs, MMDs and QMS related documents like change control, deviation, CAPA, risk assessment etc.
Monitoring of manufacturing facility and keep it cGMP compliant
Involvement during regulatory audit preparation
Co-ordination with cross functional teams like QC, QA, Maintenance, Warehouse, Injection etc.
Training and mentoring new joinees
Keep the track for calibration and qualification activities, for example for equipment, weighing scale and standards etc.
Preparation and maintenance of virus stocks and cell banks