Executive/Sr. Executive-Manufacturing (Tablet/Capsule)

2 - 6 Years of Experience rupess outline icon

Not disclosed time outline icon

Full Time

Amneal Pharmaceuticals LLC

time outline icon Ahmedabad, Gujarat, India

Posted on 16-08-2022

1 Vacancy

Description

Candidates should have hands on experience along with knowledge of 21 CFR compliance in equipment’s like RMG, FBE, Glatt, Co-Mill, V-Blender, Bosch capsule Filling machine, Fette compression machine, Auto coater, CVC Line and packaging line equipment with Track and Trace system.
Knowledge of Quality Management System (QMS) i.e. change control, Deviation, CAPA, and documentation in manufacturing/Packaging area of OSD.
Able to understand & have relevant knowledge of SCADA operation & 21 CFR requirements.
Able to understand & operate fluid Bed equipment.
To supervise and monitor day to day activities of processing and holding of drug product as per define and approved procedures for stability batches and commercial batches.
To maintain the areas and equipment in orderly manner as per cGMP requirements in a good state of repair and sanitized condition.
To impart training of operation and cleaning related SOP to all subordinates and operators.
Co-ordination for IQ / OQ for any new equipment / system.
To perform PQ for any new equipment / system.
To follow all concern departmental SOP’s for day to day operation and cleaning.
To handle and manage material movement as per defined procedure and approved Batch Manufacturing Record.
Able to understand &operate fluid Bed equipment.
To have knowledge of 21 CFR and audit trails etc.
To perform online documentation with respect to departmental procedures as per good documentation.
Maintaining the change parts for all equipment at manufacturing.