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Job Description
- The position holder is responsible for designing and maintaining the validation system and ensuring the appropriate validation policies and procedures are in place within the Quality Management System.
- Ensuring the equipment, manufacturing and testing facilities and utilities serving the facilities are validated and any revalidation studies are performed.
- Authoring and maintaining the Validation Master Plan for the Production and Quality Control areas of the site and support areas,
- Review the validation protocols and validation reports that are prepared by the validation team.
- Close coordination with GMP System Manager to maintain the quality system and detect areas for development and continual improvement.
- Participate for ensuring that GMP standards are applied based on Local Authority, WHO requirements and Otsuka standards.
- Participate in designing, maintaining and continually improving the validation system in line with current national and international standards.
- Participate in the implementation and ongoing improvement of validation policies and procedures.
- Participate in technical expertise and guidance on validation policies and procedures and the implementation of those within the Operations functional areas.
- Participate in Designs, authors and aids in the execution of validation protocols.
- Developing and executing matrix type validations where applicable for processes and equipment with adequate supporting rationales.
- Oversight and execution of validations for production, manufacturing and cleaning processes.
- Participate in ensuring validation studies of the operations and quality control facilities, the utilities serving the facilities and manufacturing/operations areas, and testing equipment are completed to the required cGMP standards.
Job Requirements
- Bch. In Science or pharmacy.
- Minimum of 9 years of experience in the field.preferred Sterile area
- Good command of English both written and spoken and computer skills.
- Management, leadership and decision making skills
- Problem-solving skills.
