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QA Team lead

Expired
  • Salary: Negotiable
  • Job type: Permanent
  • Location: Munster
  • Sector: Science
  • Date posted: 07/02/2018
  • Job reference: J381237A

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Quality Assurance Team Lead

Job Purpose:

To support the Head of Quality and Quality Assurance Manager with the development, implementation and maintenance of the quality standards and systems to ensure that products comply with Product Specification Files, Investigative Medicinal Product guidelines, documentation, specifications and cGMPs. To lead and develop the Quality Assurance Officers. To ensure project plans and milestones are delivered according to agreed timelines.

Responsibilities:

  • Actively plan Quality Assurance functions requirements; ensuring major milestone targets for each project are visible to all team members and key stakeholders to achieve on time market entry.
  • determine tasks and resources required to deliver each project milestone and deliverables.
  • To ensure that all work carried out follows the required standards conforming to company, cGxP, SOPs, regulatory regulations and guidelines, safety and environmental guidelines.
  • Ensure high quality output - Vigilantly watch over job processes, tasks and work products to ensure freedom from errors, omissions or defects.
  • Initiate action to correct quality problem and notify others of quality issues as appropriate. If a procedure does not exist, devise one, (through the appropriate channels); if a process needs amending, do so through the appropriate channels.
  • To identify and make recommendations for improvements as part of a team within or outside the department in order to ensure continuous improvement. Highlight opportunities for system optimisation to team members.
  • To ensure review of all QC and production batch documentation when required and correctly in order to achieve a high level of customer service and cGMP.
  • To ensure preparation of Submission Documentation in support of licence applications
  • Coaching / Mentoring - support members of team with problem solving and skill development to aid learning and early problem resolution.
  • Recruitment - assist with recruitment of team members in line with resource requirements and to job spec.
  • Ensure that customer/ Contract services Technical Agreements are initiated and maintained.
  • Ensure QA metrics generated monthly
  • Ensure that all customer requests are dealt with within a reasonable timeframe and are extensive
  • Ensure R&D meetings are attended and related trackers are maintained and timelines are agreed and achieved.
  • Ensure that Quality Management System meeting schedule is established and maintained and that QA are present to facilitate these meetings
  • Ensure that the Batch documentation, Laboratory results and related Quality Systems are correct and approved prior to any QA/QP release require
  • Ensure Self Inspection Program is maintained
  • Manage and Lead/ Participate in outside Inspections (Customer audits / Regulatory inspections)

Minimum Qualifications & Experience

  • Qualified to a minimum of degree level, preferably a Science degree incorporating Quality Assurance
  • At least three years' experience working in a Quality Assurance role in a manufacturing environment.
  • Lead Auditor qualification an advantage
  • Supervisory Management qualification an advantage
  • Minimum 1 years' experience in managing a team of direct reports

For more information on this and other similar opportunities, please contact Kathryn on 016455244 or email