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

وصف

Description:

Commissioningand Qualification Engineer

Overview:

Commissioningand Qualification (C&Q) engineer for various capitalprojects. Ensure the C&Q activities associated with variouscapital projects are completed safely, as per schedule and incompliance with GMP and Quality Requirements.

KeyResponsibilities:

Coordinates and Supervisesall C&Q activities.
Generate C&Qplanning documents detailing overall strategy for theproject.
Develops the master list ofC&Q test documents and activities.
Generates all C&Qsummary reports.
Ensures the C&Qschedule is developed and maintained.
Generation of allC&Q test documents (C&Q Plan/Set toWorks/FAT/SAT/IV/FT/C&Qsr)
Manages Daily C&Qcoordination meetings.
Responsible for OverallTracking and Reporting of C&Q status andrisks/issues.
Ensures Startup ofequipment/utilities is completed in a safe and coordinatedmanner.
Assist in the development ofUser Requirement Specifications (URS s) and Quality Risk Assessmentfor Equipment and Automated Systems (QRAES)

Requirements

Education/Experience:

6+ years experience inEngineering or Commissioning and QualificationManagement
Technical qualification atthird level or equivalent in Engineering.
Extensive knowledge anddemonstrated experience managing Commissioning and Qualificationfor Pharmaceutical / Biotechnology projects
Experience of sterile /biotech equipment within the pharmaceutical industry ispreferred.
Knowledge of safety, GMP andenvironmental regulatory requirements.
Demonstrated strongCommunication and Leadership skills.
Demonstrated ability tocollaborate with senior stakeholders to achieve optimaloutcomes.
Strong understanding of arisk based approach to commissioning and qualification within thebiotechnologyindustry