Description
QA Specialist required to join a global biotechnology company in Ireland for an initial 12 month contract.The QA Specialist will be a core member of the project team that is designing, building, commissioning, and ultimately achieving regulatory approval for ongoing commercial operations of a new state-of-the-art pharmaceutical packaging facility. This person will serve as the Quality reviewer and approver on project milestones and documentation such as risk assessments, commissioning, qualification, and validation activities.
This person will serve as the QA team member on one or more of the cross functional project teams: syringe filler, formulation, component preparation, automation, clean utilities, warehouse expansion.
Key Responsibilities:
* Collaborate with cross functional team to deliver project deliverables on time, on budget, and with Quality requirements being met
* Review and edit project documentation ensuring that Quality requirements are met
* Provide QA approval on finalized project documentation
* Contribute to equipment and process risk assessments
* Provide QA oversight for equipment qualification and commissioning activities including but not limited to factory acceptance testing and site acceptance testing
* Evaluate validation protocol content and execution
* Is a champion for safe working practices and safety initiatives within their area
Basic Qualifications:
* University degree. Engineering or Science related discipline preferred
* Significant experience (10yrs +) working in the pharmaceutical or biotechnology industry
Preferred Qualifications
* Excellent written and verbal communication skills
* Experience working with dynamic cross-functional teams and influencing decisions
* Experience working in aseptic operations, protein formulation, syringe filling
* Experience working with isolator and e-beam technology
* Experience with ASTM 2500 approach to equipment commissioning and qualification
* Understanding/experience with Trackwise, Change Control Management System, EDMQ and SAP
* Knowledge of applicable Regulatory requirements
* Experience with Regulatory inspections
* Operational Excellence experience
If this is you please apply today.