We’re currently recruiting for an exciting opportunity with an award-winning pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.
Duties
The Quality Assurance Technical Support (QA TS) Specialist is a senior position within the QA function which will typically report to QA Manager and will be required to be a Subject Matter Expert in their assigned area of responsibility.
ADL are implementing an extension to current Clean Utilities system, project scope includes
• New WFI Still, Storage Vessel & WFI Loop
• New Purified Water Generation Skid, Storage Vessel & Loop
• Provide QA support and oversight for CQV activities associated with the above ‘Clean Utilities project’
• Quality review and approval of C & Q documentation
o Review of Risk Assessments, DS, URS & QRAES documents
o Review of validation Plans, Protocols, FAT, SAT, IQ, OQ, PQ and associated validation documents
o Review of executed validation documents and reports
• Perform all activities in compliance with safety standards and SOPs
• Be involved in all Validation Cross Functional Teams (CFTs) at the site to ensure adherence to required policies and procedures.
• Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations.
• Provide Quality direction and input at Change Control and Deviation Review Boards and assume QA oversight of change control and Deviation/CAPA records; ensuring scope of record is clear and implementation activities are robust and timely.
In line with business requirements, these responsibilities may expand or otherwise include additional areas of responsibility which are not described in this specification but are associated with the role
Preferred Qualifications
Education & Experience
• University degree. Science or Engineering related discipline preferred.
• Relevant experience (7 yrs +) working in the pharmaceutical or biotechnology industry as a Subject Matter Expert providing quality direction of introduction of significant project such as Clean Utilities project
• Ability to work independently and remotely with minimum direct supervision.
• Critical thinking skills.
• Strong organisational, communication, coordination, and meeting facilitation skills.
• Independent, self-motivated, organized, able to multi-task in project environments and skilled in communication and collaboration.
• Team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.
