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Job Description
- Establish & implement internal & external audit plans & checklists of the management systems implemented ISO 9001,14001 HACCP, Global Gap
- Perform GAP analysis between the actual & desired management systems.
- Improving the reporting system to comply with system requirements.
- Plan for the traceability trials of company production.
- Preparation of SOPs according to guidelines.
- Review of SOPs for Quality departments.
- Responsible for documents control, issuance, distribution and withdrawal of the obsolete versions e.g. Specifications, protocols and plans from all departments.
- Responsible for daily issuance, stamping and revision of the required BPR and BMR for production.
- Responsible foe assuring the destruction of all obsolete documents.
- Responsible for review batch records.
- Responsible for filling and archiving system of all documents.
- Responsible for planning of warehouse & D.Cs audits & inspection.
- Responsible for the supplier approval audits, selection & approval.
- Responsible for training plans preparation & coordinating its implementation regarding quality principles.
- Responsible for ensuring regular Calibration of laboratory instruments.
- Supervise and follow up the change control of documents in all departments.
Job Requirements
Practical Experience
- 6-10 years at least practical experience in quality function, preferred in pharmaceutical industry.
- Managing investigation processes and testing laboratories for incoming material for at least 3 years.
- Very good awareness of Quality control and Quality Assurance activities.
- Building a new system for quality control and create documented procedures himself is a must.
