Excellent opportunity for an experienced Validation professional to branch out
I am delighted to be able to bring this opportunity to market for a well known client based in East Cork. This opportunity is with an international company who have strong roots in Ireland and are on the look out for an experienced Validation Specialist to join their team. This is an FDA approved, GMP regulated facility so experience within a highly regulated environment is a must. The QA Validation Specialist coordinates and/or performs the Design, Installation and Operational Qualification of new or changed process systems, equipment's, utilities and facilities. To assure cGMP compliance in all activities related to validation/qualification of process systems, equipment, utilities and facilities.
Being part of the Validation team here means that you not only get exposure to equipment validation but also have the opportunity to branch into process, utilities and facilities validation. They are a company that pride themselves on educating and developing their workforce. This upskilling leads to further internal opportunities and promotions as proven by many of their workforce today.
- To assure cGMP compliance before, during and after validation/qualification activities by assuring that all necessary procedures are implemented and are being followed on the site;
- To assure that process systems (including automated process control systems), equipment, utilities and facilities are qualified/validated according to their intended use and product requirements in accordance with Site & Regulatory Guidelines;
- To align Qualification and Validation methodologies in Automation, Engineering, Maintenance, and Production Areas to benefit systems compliance;
- To plan and/or establish Qualification/Validation requirements for each project;
- To establish the required qualification activities of new or changed systems and/or facilities within the change control process;
- Coordinate and/or perform the URS/DQ/IQ/OQ phase1 tasks, for all new or changed process/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 establish qualification/validation related procedures and documents to be followed;
- To support all Regulatory Inspections, to perform internal or external audits and be present at customer audits;
- 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
- University degree in Chemistry, Chemical Engineering, or equivalent degree in a scientific area
- 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 Processes and HVAC systems
- 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
- Experience in Delta V systems a distinct advantage;
If this sounds of interest, or if you would like to hear more then click the 'Apply Now' button below or reach out to Kellie on firstname.lastname@example.org or 021 2300 300.
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