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Job Description
- Execute validation studies throughout the facility.
- Interact with relevant levels staff to manage and facilitate the validation process from inception to completion by enlisting cooperation, and support for identified validation projects.
- execute validation tasks in different projects for new and existing areas, including manufacturing processes, plant systems, cleaning and equipment.
- Interface extensively with the QC/QA, Production and engineering departments to execute validation tasks and problems requiring validation support.
- Align with priorities to ensure critical projects meet required deadlines.
- implement all necessary Standard Operating Procedures for validation of plant processes, equipment installation and operational qualification (IQ/OQ), performance qualification (PQ) and requalification of critical systems, utilities and production processes.
- prepare the protocols and reports for process validation, hold time study, campaign length cleaning validation, IQ/OQ and performance qualification.
- Coordinate validation and IQ/OQ/PQ activities with Production, Quality Control Laboratories and outside contractors .
- Follow up overall qualification/validation activities include (HVAC, thermal mapping, machine qualification, laboratory instrument qualification, etc….).
- Ensure appropriate testing with quality control and support methods validation with R&D department is completed.
- execute the facility qualification program by preparing the protocols, monitoring the execution, and assisting production and engineering in resolving any identified problems
- Ensure accuracy and integrity of protocols, reports and documentation generated to meet regulatory authorities,
- Ensure critical deadlines are met for complex projects with quality assurance manager supervision.
Job Requirements
- Bachelor of pharmacy or science.
- 1-3 years of experience.
- Proven work experience as a Quality Assurance Specialist or similar role
- Working knowledge of tools, methods and concepts of quality assurance
- Solid knowledge of relevant regulatory standards
- Good communication skills, both verbal and written
- Excellent data collection and analysis skills
- Strong attention to detail
- Relevant training and/or certifications as a Quality Assurance Specialist
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