- 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.
Bachelor of pharmacy or science.1-3 years of experience.Proven work experience as a Quality Assurance Specialist or similar roleWorking knowledge of tools, methods and concepts of quality assuranceSolid knowledge of relevant regulatory standardsGood communication skills, both verbal and writtenExcellent data collection and analysis skillsStrong attention to detailRelevant training and/or certifications as a Quality Assurance Specialist