To approve the instructions relating to production operations and ensure their strict implementation.
To ensure that products are produced and stored according to the appropriate documentation in order to obtain the required quality.
Team lead for design and implementation of Quality Management Systems in production lines
Handling of overall operations of lyophilized and liquid injection ( Vial, ampoules, PFS, BFS ) manufacturing and support activities
Quality System development for the plant and services like Validation of Clean Rooms, equipment and all types of controlled environments.
To check the maintenance of area and equipments and ensure practices are followed as per procedure.
To ensure that the appropriated validations are done.
To ensure that the required initial and continuing training of department personnel is carried out and adapted according to need.
Authorization of written procedures and other documents, including amendments.
Ensure Training schedule related to onjob, cGMP and external.
Monitoring and compliance with the requirements of cGMP.
Inspection, investigation, and taking of samples, in order to monitor factors which may affect product quality.
Coordination with marketing/concern department for production planning.
Ensure the CIP / SIP of equipments, Filtration and integrity testing during processing.
Reconciliation of product , materials after the batch completion.
Audit preparations and Handling of various regulatory and third party cGMP audits.