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Job Description
- Preparing and implementing quality assurance policies and procedures.
- Identifying and resolving workflow and production issues.
- Devise sampling procedures and directions for recording and reporting quality data. Investigate customer complaints and non-conformance issues.
- 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.
- 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.
- Prepare documents needed for ISO 13485, CE mark.
- In process control activities & walk through in production areas to check conformity on systems
- Walk through for utilities (HVAC system, water station) & ware houses.
- Management for non-conformities.
- Prepare & implement validation & qualifications protocols.
Job Requirements
- Bachelor of pharmacy or Science.
- 4-6 years of experience.
- Industrial field background is a MUST.
- Good communication skills.
- Preferably SAP user.
- Males ONLY.
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