Quality Assurance Specialist / Dublin

We have an exciting opportunity for a Quality Assurance Specialist for our Multinational Biopharmaceutical Client in South Dublin on an initial 12-month contract with huge potential to extend.

The Quality Assurance Technical Support (QA TS) Specialist is a senior position within the QA function which will typically report to a QA Mgr or Senior Manager and will be required to be a Subject Matter Expert in their assigned area of responsibility.

Key Responsibilities:
* Accountable for Quality oversight processes and procedures related to Packaging Technology Transfer/NPI, Validation and Engineering.
* Quality review and approval of Transfer, Validation and qualification documentation and SOPs to support site validation activities:
o Review of DS & QRAES documents
o Review of validation Plans, Protocols, IOQ, PQ and associated validation documents
o Review of executed validation documents and reports
* Quality Review and approval of MBRs and BOMs.
* Perform all activities in compliance with the client's 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:
* 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 for NPI/ technology transfer / packaging projects.
* Knowledge of devices/combination products regulations
* 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.