SPGL is a dynamic and well established professional technical services group, operating in a range of market sectors including Bio-Pharmaceuticals, Medical Devices & Diagnostics, Healthcare, Regulated Consumer Products, Chemicals & Mission Critical. We are a responsible, diverse and inclusive organisation, driven by our vision of ‘making quality a way of life’ and a strong desire to achieve more for our customers. We are proud to have a great team of highly skilled, smart professionals who help, care and support both our clients and each other.
-
Project experience with rolling out software packages with Pharmaceutical Manufacturing Validation (CSV) experience
-
Date Migration activities
-
Development, implementation and execution of URS, SIA, DQ, IQ, OQ, PQ, RV and TM activities.
-
Performs validation of systems for which there is industry precedence but standards require interpretation to the particular case and in accordance with cGMP , cGLP’s
-
Ensures projects (moderate scale & complexity) are managed in conjunction with cGMP regulatory standards.
-
Keeps current on emerging validation regulations and validation testing practices in order to meet or exceed cGMP requirements.
-
Provides technical assistance on current US FDA and EU validation requirements.
-
Generates validation documentation (protocols/reports) and aids with the execution of protocols for computerized systems.
-
Responsible for the validation documentation through approval and implementation.
-
Provides input in review/assessment of changes to as whether they impact the validated status and validation-documentation, as appropriate.
-
Investigates/troubleshoots moderately complex validation problems.
-
Develops moderately complex protocols to ensure quality standards.
-
Bachelor’s or master’s degree in Science (Chemistry), Engineering or IT.
-
Strong communication skills
-
Capable of working independently and learns fast
-
Able to execute project to plan
-
Competent knowledge of Computer Systems Validation
-
Knowledge of validation publications
-
Full understanding of relevant quality and compliance regulations
-
Capable of troubleshooting validation issues associated with projects, process Validation Engineer Computerized systems
We are a people centric company where our staff are the heart and soul of our organisation. If you’re looking for a forward-thinking workplace and see yourself as a dynamic professional, come and join our team and you can expect:
-
Competitive starting salary
-
Excellent private healthcare
-
Pension and life insurance
-
A variety of challenging projects, with blue-chip customers
-
International project assignments
-
Continuous training and personal development
-
Strong career pathway
-
A mix of young and experienced professionals
-
Multi-cultural and caring organisation
-
An equal opportunity employer
-
Regular team building events and social gatherings
For further information on this role please e-mail [email protected]
