Clinical Coding Technician - Riyadh, المملكة العربية السعودية - Gama Hospital

وصف

Description:

Commissioning and Qualification Engineer

Overview:

Commissioning and Qualification (C&Q) engineer for various capital projects. Ensure the C&Q activities associated with various capital projects are completed safely, as per schedule and in compliance with GMP and Quality Requirements.

Key Responsibilities:

Coordinates and Supervises all C&Q activities.
Generate C&Q planning documents detailing overall strategy for the project.
Develops the master list of C&Q test documents and activities.
Generates all C&Q summary reports.
Ensures the C&Q schedule is developed and maintained.
Generation of all C&Q test documents (C&Q Plan/Set to Works/FAT/SAT/IV/FT/C&Qsr)
Manages Daily C&Q coordination meetings.
Responsible for Overall Tracking and Reporting of C&Q status and risks/issues.
Ensures Startup of equipment/utilities is completed in a safe and coordinated manner.
Assist in the development of User Requirement Specifications (URS s) and Quality Risk Assessment for Equipment and Automated Systems (QRAES)

Requirements

Education / Experience:

6+ years experience in Engineering or Commissioning and Qualification Management
Technical qualification at third level or equivalent in Engineering.
Extensive knowledge and demonstrated experience managing Commissioning and Qualification for Pharmaceutical / Biotechnology projects
Experience of sterile / biotech equipment within the pharmaceutical industry is preferred.
Knowledge of safety, GMP and environmental regulatory requirements.
Demonstrated strong Communication and Leadership skills.
Demonstrated ability to collaborate with senior stakeholders to achieve optimal outcomes.
Strong understanding of a risk based approach to commissioning and qualification within the biotechnology industry