Assistant Manager Quality Assurance

Experience – 7+ Years

Education – MSC

Gender – Male

Job Location – Lonavala

About Role

  • 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.

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