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Job Details

Quality Assurance Systems Manager

Company: Thornshaw Recruitment
Location:
Reference: TD0802
Closing Date: 23 Mar 18
Type: Permanent
Salary (£): Competitive
Benefits:

Job Summary:

M client is a clinical-stage biotech company dedicated to the development of innovative therapeutics for Alzheimer’s Disease (AD).   Due to growth and progression they are now recruiting for a Quality Assurance Systems Manager.   This role will be based in their Dublin location.

Requirements:

M client is a clinical-stage biotech company dedicated to the development of innovative therapeutics for Alzheimer’s Disease (AD).   Due to growth and progression they are now recruiting for a Quality Assurance Systems Manager.   This role will be based in their Dublin location.

Job Objective:                                  

As Quality Assurance System manager, your role will be to implement a companywide standardised system of Quality Assurance across  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  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 the organisation.

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,

For full details on this opportunity please contact me by email to tdunne@thornshaw.com or call directly on +353 1 2784701

Log on to www.thornshaw.com for a list of all current vacancies

M client is a clinical-stage biotech company dedicated to the development of innovative therapeutics for Alzheimer’s Disease (AD).   Due to growth and progression they are now recruiting for a Quality Assurance Systems Manager.   This role will be based in their Dublin location.

Job Objective:                                  

As Quality Assurance System manager, your role will be to implement a companywide standardised system of Quality Assurance across  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  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 the organisation.

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,

For full details on this opportunity please contact me by email to tdunne@thornshaw.com or call directly on +353 1 2784701

Log on to www.thornshaw.com for a list of all current vacancies

Apply for this job: Quality Assurance Systems Manager

Contact Information:

Address:  Head Office
Barton House 6 Old Dublin Road Stillorgan Co. Dublin

Rep. Ireland
Tel:  00 353 (1) 278 4671
Fax:  00 353 (1) 278 4672
Website:  Visit Our Web Site

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