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quality assurance manager

  •  Devise procedures to inspect and report quality issues
  • Monitor all operations that affect quality.
  • Supervise and guide inspectors, technicians and other staff.
  • Appraise customer requirements and make sure they are satisfied.
  • Report all malfunctions to production executives to ensure immediate action.
  • Facilitate proactive solutions by collecting and analyzing quality data.
  • Keep records of quality reports, statistical reviews and relevant documentation.
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quality assurance manager

  • Responsible for co-ordination between Production, Quality Control Laboratory and Warehouse.
  • Responsible for the establishment of Preliminary Vendor Selection and Vendor Qualifications.
  • Responsible for implementation of Quality Risk Management throughout the product life cycle from Product Development till product dispatch & distribution.
  • Impact Analysis during evaluation of Change Controls, Deviations, Incidents and other Quality Management Systems.
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quality assurance manager

  • Review of Stability data and assignment of shelf life.
  • Successfully participated & represented the organisation in many Regulatory inspections such as WHO GMP, STATE GMP, NDA – UGANDA, MOH – DR CONGO, FMHACA – ETHIOPIA, FDA – GHANA, NMPB – SUDAN, NAFDAC – NIGERIA, TFDA – TANZANIA, PPB – KENYA, PMPB – MALAWI, FDA – PHILIPPINES and also many customer audits.
  • Responsible for Product Permissions, WHO GMP COPPs and Free Sale Certificates applications to State Licensing Authority.
  • Responsible for the Manufacturing License and WHO GMP renewal applications to State Licensing Authority & National Regulatory Authority with related documentation.
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quality assurance manager

  • Conduct all of the inspections of the facility with the USDA and FDA.
  • Well versed in both FSMA and HARPC programs
  • Maintain proper documentation for food safety and compliance. 
  • Responsible for Loan License applications to State Licensing Authority with related documentation.
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quality assurance manager

  • Responsible for the other miscellaneous Regulatory Applications such as Performance Certificate, Non-Conviction Certificate and Whole Sale License to State Licensing Authority.
  • Responsible for Export NOC applications and applications for the extension of shelf life of the products to State Licensing Authority & National Regulatory Authority with related documentation.
  • Responsible for the review of Product registration dossiers as per CTD and ACTD guidelines for many African and ASEAN Countries.
  • Successfully handled queries raised by many International Regulatory bodies like TFDA – Tanzania, NDA – Uganda, FDA – Myanmar, PPB – Kenya, NDSO – Lesotho, PMPB – Malawi etc. while processing the product registration applications.