Fadia Hakim Email & Phone Number

Woodbridge, ON

Mississauga ON

Toronto, Canada Area

• Quality Management System: Ensure compliance to standard requirements (ISO9001:2008, IMS, CFIA, HACCP, GMA Safe, etc.)
• Customer complaints: Manage complaints using on-line database (KMS). Form teams to investigate root cause and implement corrective actions.
• Internal and External audits: Arranging audits, creating schedules, training of personnel, preparation, issue and close out findings (SMAC List), reporting, tracking, elevation of issues.
• Document Control: Manage on-line document control program (ETQ) to ensure all relevant documents are up to date and accessible by all employees.
• Calibration Program: Managing the calibration/maintenance of all lab equipment I also completed my Lean/Six Sigma Black Belt Training in Sept 2011 and have lead projects and worked on teams to continually improve our.

Mississauga, ON

• Oversee Quality Management System to ensure compliance to ISO 9001:2008, GMPs, and Silgan Corporate requirements (which include HACCP)
• Leader Auditor for Corporate Audits conducted for various Silgan Canadian Plants (covering GMP, ISO, HACCP).
• Create policies/procedures for newly constructed ISO Class 8 Cleanroom to ISO 14644 requirements
• Perform internal plant audits and present findings to the quality, production and maintenance departments.
• Develop, review and implement corrective action plans to resolve issues within the Quality System and assign tasks to be completed in a reasonable time frame
• Perform statistical analysis on new mould qualifications and in-process testing to ensure all processes meet CpK requirement.

Mississauga

• Successfully developed a Quality Program that was approved by Health Canada in order to obtain a Drug Establishment License
• Ensured all testing of raw materials, manufactured bulk and finished products are performedcorrectly and in accordance with Standard Operating Procedures
• Regularly audited quality records to ensure compliance to Good Manufacturing Practices as outlined by Health Canada
• Ensured all plant personnel follow Good Manufacturing Practice by conducting training sessions on a regular basis
• Performed scale up of lab batches for large scale production in plant facility.
• Maintained customer contact to ensure all products were produced in accordance with customer standards and specifications.

Mississauga

• Tested bulk batches to guarantee quality by ensuring that the results meet the product specifications. E.g. pH, viscosity, colour, specific gravity, etc.
• Performed in-process quality checks at regular time intervals to ensure finished products meet specific requirements.
• Compiled records (E.g. batch test results, micro results, and incoming raw materials) in a well organized manner that follows GMP.
• Operated and maintained laboratory equipment such as pH meter and viscometer by performing daily calibrations.