Category
Engineering
Publish Date
Tuesday 11-04-2023
Country
Egypt
Gender
any
Years Of Experience
1 - 2 Years
Salary
Negotiable
A multinational company located in Almaza is hiring a Qualification Specialist position
Job Description
- Generate Qualification Periodic Review Assessment to Manufacturing, Packaging Equipment classified, and GMP utilities according to frequency as determined by system classification and risk as defined in procedures and policies
- Review system classifications and risk of equipment and utilities and update as needed
- Perform Periodic Monitoring ofmanufacturing equipment, packaging equipment, and utilities to ensure that the equipment ismaintained in a validated state
- Provide support to the Process owner to review the validation life cycle to ensure the equipment compliance with regulatory and company policy requirements and address mitigation actions as they arise
- Ensure that the periodic review plan is achieved and on track and collaborate with stakeholders on plan attainment
- Address the periodic review reports
- Review and update procedures, managing and collaborating on the procedural documentation with the required stakeholders, as applicable
- Revise quality records including Deviations, Change Control, and CAPAs, and determine the cumulative impact onequipment and utilities’ validated state
- Support the design and implementation of a robust and compliant framework of CGMP policies, procedures, and processes
Qualifications:
- B.S. degree required in Engineering or Science discipline with a minimum of 2 years of experience in pharmaceutical
- Knowledge of validation principles, standard concepts, practices, procedures, and requirements in GMP-regulated environments
- Knowledge of QA terms, tools, and methodologies.
- Working knowledge of MS Office
- Knowledge of GMP and environmental regulations applicable to the pharmaceutical Industry.
