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Aseptic Specialist

SAUDIBIO - سعودي بايو
Riyadh, Saudi Arabia
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Aseptic Specialist

Riyadh, Saudi ArabiaPosted 8 days ago
1 open position
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Department: Aseptic ProductionEmployment Type: Full TimeLocation: SudairDescriptionResponsible to validate and establish the aseptic process as a Subject Matter Expert (SME) that includes aseptic process simulation and other related activities and tasksCoordinating the collective efforts of other departments or outside contractors / Vendors to complete aseptic operation project tasksProvides technical support in the process technology, implementation and scale-up. And to support feasibility studies with external stakeholders.Developing interpersonal capabilities in the areas of aseptic production and Providing training, support, and guidance to all team members of Aseptic production.Responsible for aseptic process validation and qualification activities by means of end-to-end validations such as from Change control, URS to PPQResponsible for complete Commissioning & Qualification activities of Aseptic production as per the regulatory needs and strive to reduce expenses and increase productivityAuthoring and Reviewing GMP documents of aseptic production department, such as qualification and validation protocols, summary reports and associated data for conformance to regulations and SOPs, but not limited to.Working with Aseptic production team effectively to achieve the strategic goals and objectives of the organization.Proactively support the quality management System elements of aseptic production departments such as deviation notifications, investigations, CAPA, change management and Risk assessments.Skills, Knowledge And ExpertiseBachelor's degree in pharmacy (preferable), Chemistry, Biotechnology or Engineering.Master's degree in pharmacy (preferable), Chemistry or Biotechnology.7 to 8 years of experience in Pharmaceutical/ Biotechnology Manufacturing Organization.Experience in Aseptic filling process with islolators Experience in Cartridge filling Experience in Washing & Sterlization Experience in Commissioning & Qualification
JobsR&D/ScienceAseptic Specialist