Department: Aseptic ProductionEmployment Type: Full TimeLocation: SudairReporting To: Assistant ManagerDescription| Area of Responsibility | 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.| 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.| Skill, knowledge, expertise || Educational qualifications || Bachelor of Pharmacy| Experience || 10 to 15 years| Technologies/ Markets || Experience in Formulation of insulin/ Biological products| Experience in Commissioning & Qualification| Working in Aspetic Area