Description
Main Activities:*Coordinate and/or carry out the URS/DQ/IQ/OQ tasks, for all new or changed proces/utilities systems in close liaison with the Engineering area,
*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 assure and promote compliance on Health, Safety and Environment in the area and activities for which is responsible or in which participates
*To establish qualification/validation related procedures and documents to be followed.
*To be present at customer audits;
*To support all Regulatory Inspections
*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:
Background: University degree in Mechanical, Chemical Engineering, or equivalent degree in a scientific area.
*Minimum of 2 to 4 years experience in commissioning, qualification and validation;
*Thorough understanding of cGMP and ISPE and GAMP Guidelines
*Excellent communication skills;
*Ability to discuss technical aspects of Qualification and Validation with clients, suppliers and health authorities;
*Proactive approach to all activities - "Can do - Will Do" attitude
*Excellent attention to detail with a analytical and objective approach to review
*Must be able to work on own Initiative with minimal supervision
*Minimum of 3 years experience in Qualification & Validation work;
*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
This is an exciting and urgent position, with the potential to earn competitive hourly rates. If you are interested or know anyone who might be, please contact Sarah Irvine on immediately.