Title: Senior Quality Assurance Specialist - QA Technical Support Specialist
Location: Dun Laoghaire
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.
* Provide QA support and oversight for a range of technical projects, including New Product introduction to Packaging lines, introduction of new manufacturing equipment (ex: new packaging line, new AVI, new vessels, freezers, etc..), IS, Computerized Systems & Automation projects (ex: BMS, PCS, FMS, HMI upgrades etc..)
* Quality review and approval of qualification/validation 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.
Qualifications and 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.
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As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.