GerTEK is an engineering consultancy company specialising in project management, talent solutions and commissioning qualification and validation services.
We partner with many of the world's largest life sciences & technology companies who entrust in us to deliver their most strategic and important projects.
Purpose
To coordinate the development and maintenance of the company's validation program in compliance with all applicable regulatory and company requirements.
Co-ordination, implementation and active participation in the site Validation Program.
Responsibilities
Ensure all Computerized systems are qualified in compliance with Data Integrity policies and regulatory requirements.
Co-ordination / direction and active participation in the validation of site equipment, facilities, utilities, processes and software in compliance with company policies, FDA, European cGMP and GAMP standards.
Generation/maintenance of the Validation Master Plans.
Generation/maintenance of Project Validation Plans.
Generation of validation plans, protocols and final reports to cGMP standard.
Understanding of Risk based equipment qualification, Equipment Risk Assessments, Critical Elements Test Plan development.
Review / approval of all protocols and final reports.
Management of validation change control process.
Adheres to and supports all EHS & E standards, procedures and policies.
Qualifications
3rd level qualification in a relevant engineering or scientific discipline.
Job/Technical Skills
A minimum of 5-10 years' experience in a cGMP regulated environment.
A good understanding of regulatory requirements.
Must have hands on experience of execution of IQ/OQ/PQ for Facilities/ Utilities/ Equipment in Pharmaceuticals or Medical Devices or Diagnostics.
Work location - Onsite
Job type - Full-time
To start the process click the Continue to Application or Login/Register to apply button below.
#J-*****-Ljbffr