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Job Description
- Ensure Compliance of validation activities to International Regulation and Guidelines (ex. EU , ISO, WHO, FDA,
- Responsible for qualification of sterile area equipment.
- Responsible for Validation and Qualification Activities for HVAC and utilities .
- Responsible for Process validation of sterile and non sterile products .
- Responsible for Cleaning Validation in sterile and non sterile area .
- Responsible for risk assessment for relevant validation activities.
- Managing Site Calibration System
- Maintaining frequencies protocol and report for Media Fill .
- Keep records related to different validation activities.
- Represent the site for validation during external audits.
- Responsible for thermal mapping.
- Managing third parties in case of outsourced qualification activity
Job Requirements
Qualifications:
- Bachelor of Pharmaceutical Science
Experience:
- 8-10 Years of experience in Validation of pharmaceutical industries preferable in sterile area.
- Experience in EMEA, FDA certification
- PC knowledge and English language
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