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QA Validation Lead(North Dublin)
1 month ago
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Responsibilities:- Qualification of Computer system qualification.
- The QA Validation lead must possess strong initiative and be capable of working both independently and collaboratively across the organisation.
- Strong interpersonal, communication and presentation skills are required for this position as well as good time management, multi-tasking and organisational skills.
- Familiarity with ALCOA+ Data Integrity and Compliance Assurance.
- Assessment of changes for GMP compliance in accordance with site change control procedure for facilities, utilities, lab and manufacturing equipment and control system changes.
- Laboratory equipment validation and NPI's.
- Review and approve the GMP design aspects of major capital projects including Software upgrading, Qualifying/validation Recipes.
- Ensure all quality systems are implemented/executed in compliance with ICH Q7, Eudralex, 21 CFR and site Quality standards.
- Provide expertise in the area of validation ensuring compliance with current industry regulations, guidelines and trends. Reviews master and complete qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria.
- Knowledge on Risk-Based Validation for IQ/OQ/PQ.
- Participate in other projects as directed by the Quality Systems & Validation Manager.
- High level interaction with the various functions on site: Manufacturing, QC, Utilities and Engineering.
- Min of BSc/BEng in Computer application/Engineering or a science-related discipline with at least 4-5 years pharmaceutical experience ideally in a CSV role.
- Must have experience leading projects with a small team (1-2 people).
- 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.
Mid-Senior level
Employment Type:Full-time
Job Function:Engineering and Science
Industries:Architecture and Planning
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