Responsible for overall Quality Assurance / Quality Control Activities.
Responsible for release/rejection of Starting and In-process Materials.
Review and release of Batch Processing and Packaging records.
To ensure that production operations are carried out in accordance with Good Manufacturing practices and applicable regulations.
Responsible for release/rejection of Finished product as per MA specification and in accordance with GMP requirements.
Ensuring product dispatches in compliance with GDP requirements.
To ensure that the training of all personnel is carried out according to need & records maintained thereof.
To ensure that all changes are monitored through change / Exceptions Management module.
To approve process non conformance and material non conformance.
Review and authorize all documents/Minor Change Controls.
To ensure that awareness of cGMP requirements are evaluated and updated through periodic training and audits.
To follow and implement Quality Management System related procedures.
To ensure complaint handling and investigation with appropriate measures to prevent reoccurrence.
Review and authorization of product complaints and investigation reports.
Review and implementation of audit observation compliance report.
Review and approval of out of specifications and investigation reports.
Ensure that a system is available to recall any batch of product from sale or supply and responsible to investigate the reasons for recall.
Responsible for CAPA coordinator activities.
To ensure compliances of the validation protocols of facilities, equipment and process, cleaning, Analytical methods and system (HVAC and Water).
To approve validation procedures and establish revalidation programs.
Handling of customers and regulatory inspections.
Approval of Annual Product Review reports.
To ensure the compliance of Technical Agreements.
To authorize user ID creation for TRIMS, LIMS & empower.
To ensure that plant hygiene including cleaning and sanitation are performed and maintained.
To authorise documents in absence of Sr. Management Representative.
Approval of Batch Cards in DMS Software.
To follow and implement Environment Management Systems related procedures .
To ensure the compliance of the Empower and stand alone software administration activities including back-up and restoration of the data.
Shall be responsible for review and approval of Quality Risk Management exercises.