Description
Main Activities:- To participate in the management of Quality Systems key activities related to job mission: Quality Systems tools, Quality Systems Management (DocStream, Change Control etc), Procedures and Policies, cGMPs training;
- To prepare/review/approve Quality Systems methodologies related to the area objectives and assuring adequate training on site is provided to all departments in relation to validation/qualification activities;
- To establish qualification/validation related procedures and documents to be followed.
- To pro-actively manage all Deviations, CAPA's, Improvement Plans and Change Control activities related to Qualification and Validation of all Projects, Equipment, Facilities and Utilities
Requirements and Competencies:
- University degree in Mechanical, Chemical Engineering, or equivalent degree in a scientific area.
- Minimum of 4 years experience in commissioning, qualification and validation;
- Thorough understanding of cGMP and ISPE and GAMP Guidelines
- Must be able to work on own Initiative with minimal supervision
- Good general knowledge on Quality, cGMPs, ICH and ISO guidelines as well as experience on their application;
- Strong Technical Knowledge of Project Engineering applied to Process equipment, facilities, utilities and HVAC systems
- Formalised Training in Risk Assessment/Analysis techniques
If you would like to know more about this position please contact Sarah Irvine on or respond to this advert with an updated copy of your CV.
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