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Job Description
- Performing the IQ/OQ of utilities, machines, and equipment in cooperation with production, QC & QA [each in his area of responsibility].
- Performing all calibration activities of all equipment involved in the different processes (may hire external professional if needed).
- Establishing the SOP for Media Fill test run.
- Preparing of Media Fill Validation Protocol.
- Planning the different control points throughout the whole Validation process according to the final process objectives.
- Preparing of the Environmental Control data generated during the Validation activities
- Assurance that all activities in the Validation process during its performance are under control and complying with c-GMP requirements through revising, evaluating and approving all inputs & outputs of each activity.
- Sterile c-GMP Manufacturing Facilities: Design, Construction and Qualification.
- Qualification and validation monitoring.
- Ensure validation compliance with regulatory guidelines established by regulatory bodies and also ensure compliance with all health and safety, government regulatory standards and updating the validation and qualification activities in accordance to the most recent regulatory presses (EU, MCA, PICS, ISPE, PDA, WHO, ICH and FDA).
- Contribute to Process validation (Preparation of all required documentation as SOPs, protocols and final reports, monitoring of execution of work and statistical analysis of collected data in terms of control charts and process capability calculations).
- Prepare study of hold time validation for non-sterile production area for all dosage forms
- Prepare cleaning validation study for all production line
- Thermal mapping for all storage areas and incubators
- Prepare validation study for water station ( PW- WFI)
- Prepare of validation of HVAC system and determine the recovery time for each time
- Coordinate with external companies to validate (autoclaves-ovens, ……).
Job Requirements
- Bachelor's degree of Pharmacy or Engineering
- Experience minimum 2 years.
- Resident Cairo, Sharqia (10 of Ramadan is preferable)
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