Quality Assurance Intern

Job Description

• This role will be part of the Quality Self Directed work team/ Hubs in our state of the art single use multi-product biotech facility in Dunboyne, County Meath, Ireland.
• The organisational structure at the site will be based on self-directed work teams where decisions will be made at the level where the data exists.
• The Quality Intern will work across the site self-directed work teams and hub teams to drive proactive programmes in order to allow the site to deliver on our commit culture that support Quality, EHS, Learning and Continuous improvement.
• The overall responsibility for this role will be to support the performance of the Quality at the site according cGMP standards.
• This is an important role within the Site Quality leadership organisation to help create value for our patients.

Responsibilities (Includes, but are not limited to):

• Participate in the implementation of industry best practices specific to Quality processes that support Manufacturing, materials management, validation and Quality Control Laboratory readiness.
• Participate and help support the performance of the site Quality according to cGMP standards.
• Be a part of Quality on site where we comply with changing requirements and trends in worldwide GMPs.
• Participate in ensuring consistency of Quality across the site and for driving efficiencies.
• Build safety as a key value within the Quality teams and maintain sustainable EHS programmes that are engrained within the department.
• Ensures Quality Assurance - owned business systems are established and engage with the business systems owner to continually improve these processes.
• Pro-actively participate in the Quality Management process to ensure that the Quality System continues to function effectively and that improvement/remediation actions are taken as required.
• Continuous improvement of Quality - Identifying and building in efficiencies as necessary from a systematic and compliance perspective.
• Provide support for general troubleshooting, problem solving, technical direction and guidance to support overall business needs.
• Gain up-to-date knowledge of pharmaceutical legislation and industry best practice.
• Pro-actively participate in creating an environment of ‘right first time’ in everything that we do through a focus on principles of lean, including simplication, standard work, visual management and a learning organisation.
• Responsible for timely updates of site achievements and challenges. A collaborative approach, working cross functionally on resolving obstacles to maintain a highly effective and productive functional group
• Additional duties and responsibilities as required to support departmental objectives and business needs. These tasks may evolve over time and will be aligned with the intern’s skills, training, and development objectives, while contributing to the effective operation of the Quality function.

Qualification and and Skills Requirements (Includes but are not limited to)

• Technical aptitude (i.e. able to read and comprehend technical documentation and execute procedures.
• Excellent communication skills (written and oral).
• Ability around working cross functionally, focusing on meeting and tracking to schedules and embracing an interdependent work culture.
• Experience working in a GMP/regulated environment is desirable.
• Organisation Skills - Ability to manage multiple priorities and know when to escalate issues for resolution.

PQ20

Required Skills:

Preferred Skills:

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Relocation:

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