Sterile Manufacturing Specialist

About SaudiBio:

Saudi Biotechnology Manufacturing Company (SAUDIBIO) is a Saudi Joint Stock Company and was established in 2010. A leading biopharmaceutical company duly incorporated in the Kingdom of Saudi Arabia, SaudiBio has a multipurpose sterile fill and finish facility for biopharmaceutical products and is a leading insulin manufacturer in Saudi Arabia.

About the Job Location :

Sudair - Saudi Arabia

Working Days and Hours:

Sunday to Thursday, from 8:00 AM to 5:00 PM

Position title:

Formulation Specialist

Main Responsibilities:

• 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.

Qualifications and Experience:

Educational qualifications

• Bachelor of Pharmacy

Experience

• More than 7 years of experience in sterile injectable formulation.