Ensure the Management Review Report at a desired frequency for communicating the status of various activities with senior management.
Ensure the Release of the Finished Product after reviewing and verifying the relevant datas and documents.
Ensure the Investigate Market Complaints, maintaining Investigation records and further taking and planning proper Corrective Action and Preventive Action (CAPA)
Ensure the system of Receiving and maintaining the details regarding the Vendors for various components.
Ensure approval of deviation with proper CAPA.
Ensuring qualification activity of Equipments & utility.
Ensure the recall and return goods practice at the site.
Ensuring Preparation and review of technical documents like Validation Master Plan and Site Master File.
Ensure Preparation and implementation of work permit or modification in the facility and equipment.
To ensure training of recruit technical staff in the plant personnel prior put on job.
System the compliance of quality aspect of LLM/Third party manufacturing facility.
To update the directors on matters of unit deviations.
To have any job prescribed by directors.
Ensure the FDA/Regulatory/Non regulatory audit in plant.
Preparation of compliance report of audit and inform to regulatory time to time.
Ensure the management and inventory of Raw material and Packing material store