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Job Description
- Preparing, reviewing and implementing quality assurance policies and procedures.
- Identifying and resolving workflow and production issues.
- Evaluate adequacy of quality assurance standards.
- Devise sampling procedures and directions for recording and reporting quality data.
- Review the implementation and efficiency of quality and inspection systems.
- Investigate customer complaints and non-conformance issues.
- Collect and compile statistical quality data.
- Develop, recommend and monitor corrective and preventive actions.
- Prepare reports to communicate outcomes of quality activities.
- Identify training needs and organize training interventions to meet quality standards.
- Coordinate and support on-site audits conducted by external providers.
- Evaluate audit findings and implement appropriate corrective actions.
- Prepare and Monitor risk management activities.
- Responsible for document management systems.
- Assure ongoing compliance with quality, medical devices, safety, and Environment regulatory requirements.
- Assure ongoing compliance with In Vitro Diagnostic Directive (IVDD) Requirements.
- Responsible for Qualification execution DQ/IQ/OQ in conjunction with relevant departments ensuring timelines met
- Participates in teams assembled to specify, install, validate, troubleshoot and maintain systems, processes, or equipment.
- Assist with validation activities performed by outside validation companies; perform job responsibilities in compliance with cGMP, regulatory requirements, company policies and standards.
- Ensuring all instrumentation are compliant with the site calibration plan, non-routine calibration and fast acting in order to support production and maintaining all calibration documentations up to date.
Job Requirements
- Bachelor Degree of Science or Pharmacy.
- Preferably Industrial background.
- 3-5 years of experience .
- Resident of Badr City or near by districts.