QA Systems & Validation Specialist
Maternity Cover - 6 month contract
Swords, Co. Dublin
My client, a pharmaceutical company with over 50 years of API manufacturing experience is looking for a QA Systems and Validation Specialist to join their site in Swords, Co. Dublin.
Reporting to the QA Systems and Validation Manager this role 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.
Required Key Skills and Experience:
- 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.