- Technical Writing of Validation Documents (Risk Assessment, Validation Plan, Design Configuration/Specification, User Requirements, Functional Requirements, IQ OQ PQ, Trace Matrix, Validation Summary Report), SOPs, Maintenance Procedures, Calibration Procedures, and other instrument support documents.
- Follow up overall qualification/validation activities include( HVAC, thermal mapping, machine qualification, laboratory instrument qualification, etc….).
- Provide inputs to and administration of the site master validation program as well as assist in maintaining the site validation master plan.
- Develop validation policy with roles and responsibilities.
- Author, Review, Execute process validation protocols and validation summary reports.
- Perform validation testing and analyze data for validation documentation to determine acceptability.
- Review/assess proposed changes to validated processes via CAPA, Change Control and Work Orders to identify requirements necessary to maintain validated status.
- Production oversight during validation events
- Assist in cleaning, process and equipment validation activities throughout the plant. This includes coordinating validation and cGMP-related activities of Engineering Services, R&D, Production, Maintenance and QA/QC.
- Follow up the results of water station analysis.
- Manage the computer system validation across the facility related functions including ( laboratory equipment and system, engineering utilities, production machines,….)
- Bachelor of Pharmaceutical / Sciences.
- 1-3 years of experience.
- Very Good knowledge of English language ( Written and spoken).
- Microsoft Office Skills. (Excel – Word – PowerPoint).
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