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Job Description
Manage, supervise, coordinate, and review reports of processes validation inside production departments to verify the continuous capability of production processes to comply with local authorities, WHO and EU regulations and fulfil cGMP guidelines.
Responsibilities & Duties:
- Provide Technical assessment to determine the need for process validation activities in production in case of deviations &, changes (i.e. new material supplier’s .etc.).
- Establish risk assessment studies relevant to the validation documentation.
- Write validation protocols and reports to comply with cGMP standards.
- Attend process validation activities in production departments.
- Coordinate validation activities cross-functionally in the quality and production departments.
- Assist in performing investigations and optimization for non-compliant troubleshooting in production areas.
- Collaborate with (MOH, licensors,,…etc.) on regulatory and compliance responses related to validation / qualification issues.
- Update validation documents regularly according to cGMP regulation.
- Perform and review the validation part of CTD files for Minapharm products.
- Execute thermal validation studies, autoclave and ovens to comply with cGMP regulation, issue report & issue certificates or witness studies if performed by supplier and review its report
- Perform area qualification including its documentation
Job Requirements
- Experience from +8 years.
- B.SC of Pharmaceutical Sciences.
- cGMP.
- Process validation.
- Computer system validation.
- Advanced Knowledge of the cGMP.
- Intermediate Knowledge of Six Sigma.
- Advanced Knowledge of Process validation
- Advanced Knowledge of Computer system validation.
- Awareness of TQM.