Senior Quality Assurance Specialist

Team Horizon is seeking a Senior Quality Assurance Specialist for our client who are a leading biopharmaceutical company based in Dublin. You will report to the Senior QA Manager and will be required to be a subject matter expert in your assigned area of responsibility.

 

 

Why you should apply:

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  This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.


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  There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.


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  Our client is developing the capability to produce all its medicines in Dublin, helping to ensure continuity of supply of our medicines as they expand internationally.

 

What you will be doing:

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


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  Quality review and approval of CSV documentation.


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


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


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  Review of executed validation documents and reports.


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  Perform all activities in compliance with Amgen safety standards and SOPs.


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  Be involved in all Validation Cross Functional Teams (CFTs) at the site to ensure adherence to required policies and procedures.


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  Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations.


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  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.


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  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.


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  Any other duties as assigned 

 

What you need to apply:

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  University degree. Science or engineering related discipline preferred.


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  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 new MES or BMS system.


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  Ability to work independently and remotely with minimum direct supervision.


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  Critical thinking skills.


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  Strong organisational, communication, coordination, and meeting facilitation skills.


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  Independent, self-motivated, organized, able to multi-task in project environments and skilled in communication and collaboration.


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  Team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.