QA System and Validation Specialist - CPL IE

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.