To Implement cGMP systems for manufacturing operations.
To Review/Approve all the Quality related documents like Quality Procedures, SOP’s, BMPR’s, specifications and Integrated QMS documents.
To ensure that appropriate validations for process, analytical methods and equipment’s are performed and reports of validations are maintained.
To ensure that Product Quality Review Report is prepared reviewed and its approval has taken place in stipulated time.
To Implement Change Control System.
To ensure that Deviations, failures, non-conformances, Out to specification results and customer complaints are investigated and corrective action and preventive actions as per applicability has taken place.
To organize Self Inspections for different departments and to ensure that proper corrective actions have been taken for observed non conformances.
To generate the item codes generated for different materials.
To Perform Self Inspection of different departments.
To identify cGMP related training needs for the employees.
To Approve Certificate of Analysis (COA) issued to customers.
To support in Handling Regulatory and Non regulatory inspections.
To Release Finished products to the market.
To Perform Vendor qualification and maintaining the Vendor list.
To Allocate Batch number.
To Review / Approve Batch Manufacturing and Batch Packing Record.
To Review / Approve Change Control and Deviations.
To Review / Approve Corrective and Preventive actions.
To verify departmental trainings as per Training Calendars.
Any work assigned by General Manager QA.
To prepare Management Review Report at predefined frequency.
To fill all the records necessary for the proper implementation of Quality Management System requirements.
To attend all management review meeting as per the requirement
To evaluate effectiveness of training in consultation with HR.
To help the Organization in achieving the Objectives.
To ensure stringent follow-up of the documented quality system in the department.
Mylab Discovery Solutions Pvt. Ltd., is an Indian diagnostic company that, develops & commercializes tests used in human diagnostics, food safety, agriculture, and veterinary medicine, empowering labs to obtain reliable, timely, and actionable results.