Aseptic Specialist

دوام كامل في a Laimoon Verified Company في Saudi Arabia

نُشرت يوم October 18, 2024

تفاصيل الوظيفة

Job Description:-Responsible to validate and establish the aseptic process as a Subject Matter Expert (SME) that includes aseptic process simulation and other related activities and tasks.-Coordinating the collective efforts of other departments or outside contractors / Vendors to complete aseptic operation project tasks.-Provides 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 PPQ.-Responsible for complete Commissioning & Qualification activities of Aseptic production as per the regulatory needs and strive to reduce expenses and increase productivity.-Authoring 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.Desired Skills and ExperienceJob Requirements:-Bachelor'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 isolators. -Experience in Cartridge filling.-Experience in Washing & Sterilization. -Experience in Commissioning & Qualification.Sthree UAE is acting as an Employment Business in relation to this vacancy.

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