Job Description
The SK biotek Ireland Quality team here at the Swords Campus are looking for a QA Systems & Validation Specialist Role on an 11 month contract reporting into the Quality Manager.
Position Description:
The QA Systems Validation Specialist will be responsible for:
• Assessment of changes for GMP compliance in accordance with site change control procedure for facilities, utilities, lab and manufacturing equipment and control system changes.
• Reviews master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria. Including but not limited to:
• Qualification of premises, equipment and utilities.
• Computer system qualification.
• Laboratory equipment validation.
• Provide expertise in the area of validation ensuring compliance with current industry regulations, guidelines and trends.
• Participate in cross-functional project teams as the quality assurance validation representative.
• Review and approve the GMP design aspects of major capital projects including new facility construction, facilities upgrade, new manufacturing equipment and support systems.
• Communicate with all departments on site on a regular basis to ensure timely approval change controls to support the manufacturing schedule.
• Ensure all quality systems are implemented/executed in compliance with ICH Q7, Eudralex, 21 CFR and site Quality standards.
• Assist in the co-ordination of audit preparation.
• Review and provide input into the site periodic review and revalidation programme.
• Preparation, review and approval of GMP documentation.
• High level interaction with the various functions on site: Manufacturing, QC, Utilities and Engineering
• Participate in other projects as directed by the Quality Systems & Validation Manager.
• Strong interpersonal, communication and presentation skills are required for this position as well as good time management, multi-tasking and organisational skills.
Minimum Requirements:
• Min of BSc/BEng in Chemistry, Engineering or a science-related discipline with at least 3 years pharmaceutical experience ideally in a QA role. Preferably with experience in change control/documentation management, good manufacturing practices
• Knowledge / appreciation of other site operations such as QC, Operations, Engineering, IT.
• Some experience in Operational Excellence or project management would be desirable.
Knowledge of relevant regulatory requirements for Data Integrity, including GMPs.
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