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The Quality Assurance Specialist is responsible for supporting the quality department in the administration and implementation of the Quality Management System in the context of manufacturing, commercialisation, and post marketing GXP activities.
This position provides operational support for batch review, quality activities, collaborates with cross-functional team members and external service providers as required. There will be a requirement to attend the Dublin office to support audits and for Bimonthly team meetings.
This role gives an opportunity for an individual to further develop their career path by being exposed to many varied QA experiences in a fast-moving dynamic environment. There is also potential for the candidate to progress to become a Qualified Person in time.
Main Responsibilities
Support maintenance of Chiesi Quality Systems in line with best practice standards and support batch record review and release to ensure patient supply and compliance to registered dossiers.
GXP duties including but not limited to:
• To review and support release of Drug Substance, Drug Product and Finished product.
• Deviations review
• CAPA review
• Change Control review
• Standard operating procedures author as required
• Assist in compilation/review of Product Quality Reviews.
• Metrics generation
• Ensure compliance with all laws, regulations and policies that govern the conduct of the company.
• Participation in regulatory inspections and audits as required.
Experience Required
• A highly motivated, individual who is organised and methodical with experience in project management, analytical, problem-solving.
• Excellent interpersonal skills.
• Excellent collaboration skills to optimise the relationship with internal and external partners.
• Weekly attendance in the Dublin office.
• 3rd level qualification in a scientific discipline.
• 3-5 years industry experience.
• Knowledge of quality standards and regulatory guidelines and requirements relating to pharmaceutical and/or biotech products.
• Time management skills.
• Good prioritization capability and comfortable adapting to meet changing priorities.
• Ability to travel required. Anticipated travel: 10%
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