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R&D Quality Specialist - TEAM HORIZON

Job in Ireland
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Company: TEAM HORIZON
Full Time position
Listed on 2019-09-22
Job specializations:
  • Quality Control
    QA Manager, Quality Control Manager, Quality Manager, Quality Supervisor
  • Pharmaceutical
Job Description & How to Apply Below

The Opportunity

Team Horizon is seeking a R&D Quality Specialist who will provide day to day assistance for Clinical Trial Supplies QA activities ensuring assigned tasks are performed in a timely manner to meet Clinical supply requirements. The R&D Quality Specialist is involved in the review /and or approval of elements of the quality system.

The R&D Quality Specialist is accountable for their individual areas of responsibility within the Company’s quality system. The position holder must show the competence to drive forward the quality processes at the site and the skills to ensure that Compliance adds to the greater benefit of the facility. In association with the Quality Manager will work to meet company goals and objectives, customer requirements and the regulatory obligations as laid down by the FDA, EU and Regional Ministries of Health

The Role

  • Work with the Quality Manager on the delivery of the company quality plan and global regulatory requirements for the site
  • Manage quality requirements for process changes and new clinical studies as deemed necessary
  • Ensure effective recording, analysis and reporting of KPI’s ensuring issues impacting quality performance are addressed and drive continuous improvement
  • Demonstrate active support and involvement in successful progress of compliance initiatives to enhance the site quality program
  • Represent the company in Ministries of Health inspections as required
  • Provide quality input as required, providing direction on day to day activities as a member of the site quality team
  • Foster an environment of continuous improvements for the Compliance area by identifying and implementing efficiencies and quality improvements
  • Support process changes/validation projects where Compliance services are required
  • Coordinate GTW Management for area of responsibility
  • Preparation and review of semi-finished batch paperwork
  • Review of Clinical Packaging batch records (pre and post approval)
  • Label Approvals
  • Item Master Approvals
  • Receipt and release of Clinical Trial components
  • Coral Review and Approval of assigned documentation as deemed necessary
  • Coordinate GCS quality monthly meetings for assessment of quality system performance
  • Assist in the preparation and management of site MOH and customer inspections
  • Management of Temperature Excursion Process
  • Management of Product Specification Files
  • Management of Annual Mock Recall
  • Review and approval of GTW records and associated documentation
  • Complete assigned internal and external audits
  • Attend all routine meetings as required. For example: Daily team meetings, metrics meetings, Quality Management Review, Study Planning meetings, GTW meeting
  • The Person

  • Proven track record in a quality discipline in the Pharm/Medical Device environment
  • Third Level Science qualification
  • Clear understanding of working within a regulated environment
  • Excellent communication skills
  • Ability to use sound judgment to make effective decisions within appropriate timeframes
  • Proven to be self-directed, self-motivated and ability to prioritise competing priorities
  • High level of self-integrity and ethical conduct.
  • Position Requirements
    Less than 1 Year work experience
    Note that applications are not being accepted from your jurisdiction for this job currently via this jobsite. Candidate preferences are the decision of the Employer or Recruiting Agent, and are controlled by them alone.
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