The SK biotek Ireland Quality team at the Swords Campus are looking for a QA Systems & Validation Specialist on a 12 month contract reporting to 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, CSV.
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.
Skills: CQV CSV GMP QA