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Job Ref.: 1564

Job Title: Quality Assurance System Manager – Biotech – Dublin City based – Feb 2018 – Urgent

Posted Date: 21/02/2018

Sector: Quality

Location: Ireland, Dublin

Job Type: Permanent full-time

Job description:

Quality Assurance System Manager – Biotech – Dublin City based – Feb 2018 – Urgent

Our client is a clinical-stage biotech company dedicated to the development of innovative therapeutics for Alzheimer’s Disease (AD) and other neurodegenerative disorders. They are a multinational corporation with operations in the US (New York & Dallas), Dublin & Taiwan.

They intend to become a leading global player in neurodegenerative diseases, starting with Alzheimer’s, by developing an innovative portfolio of therapeutics based on proprietary technology platforms as well as in-licensing technologies, driven by biomarkers, and established by safety and efficacy in patients.

Job Objective:

They are now looking to recruit a Quality Assurance System Manager based in Dublin city to implement a companywide standardised system of Quality Assurance across company sites and CRO partners. The successful candidate will be involved in reviewing, maintaining, developing and continually improving the organisation’s Quality Management System (QMS) and ensuring a Quality culture is present throughout the organisation.

Responsibilities:

  • Audit / Review of existing quality management systems, processes, and frameworks.

  • Implement a quality management system to ensure that UNS global quality standard is maintained both internally within the organisation and externally with outsourced vendors.

  • Overseeing compliance with all GCP, GLP and GMP requirements.

  • Quality Enhancements - Drive quality management framework enhancements (SOP, quality metrics, process improvements etc).

  • Monitoring & oversight - Plan and conduct routine and risk-based QA audits and inspections of the quality system to provide assurance of compliance with QMS and relevant standards.

  • Ensure that audit results / other quality information are formally and consistently recorded and corrective actions/preventive actions are taken.

  • Perform staff training regarding the quality system, applicable standards and regulations and champion bests in class quality standards across UNS.

Qualifications and Requirements:

  • Bachelor’s Degree in medicine or general science.

  • Proficient in QA procedures and a thorough knowledge of GCP, GLP and GMP requirements.

  • Specialist knowledge of GMP for biologics/vaccines and sterile injectable dose forms would be an advantage.

  • 5-10 yrs quality assurance experience in progressive roles.

  • End to end quality systems implementation experience.

  • Ability to liaise successfully with cross functional stakeholders,

An excellent salary plus benefits package will apply to the successful candidate.

For further information, please call Marc Flanagan at 086 1759252 or email your c/v in the strictest confidence to marc@pharmasolutions.ie

 

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