Quality Assurance Automation Engineer

1 month ago


Dublin, Ireland Orion Group Full time

Orion Group Life Sciences are currently recruiting a QA Automation (Hyrbrid) on behalf of our Multinational Biotechnology Client based in South Dublin on initial 12-Month contract with huge potential to extend.

Key Responsibilities:

* Accountable for Quality oversight of processes and procedures related to IS, CS & Automation compliance (ex: BMS, PCS, FMS, HMI upgrades etc..)

* Quality review and approval of C & Q documentation

o Review of Risk Assessments, DS, URS & QRAES documents

o Review of validation Plans, Protocols, IQ, OQ, PQ and associated validation documents

o Review of executed validation documents and reports

* Perform all activities in compliance with the company safety standards and SOPs

* 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:

* 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 automation / IS projects

* 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.

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.



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