QA Systems Lead

  • Contract
  • Meath

Website Ref: TPM04164

Summary:
A QA Systems Lead is required for a biopharmaceutical company in Dunboyne.

Responsibilities:

  • Manage the hiring, development and coaching of members of the Quality Assurance Systems team to drive a high performance organisational culture that accommodates rapid growth and highly dynamic expectations, ensuring attainment of site operational and development goals.
  • Responsible for providing oversight and coaching to the QA Systems team on the site Quality Management Systems (Change Controls, Documentation Management, CAPAs, Audit Readiness, Supplier Quality Management, and Pest Control).
  • Monitor and support the performance of the site Quality Systems according to company and cGMP standards.
  • Implementing industry best practices specific to Quality System processes that promote manufacturing, materials management, validation, and Quality Control Laboratory readiness.
  • Taking a leadership role in promoting a culture of Compliance, Right First Time and Continuous Improvement
  • Implementing efficiency improvements in Quality Systems continuously and participating in site projects and initiatives.
  • Preparation/review, and or approval of GMP documentation, including SOPs, policies, analytical documentation as required.

Qualifications & Experience:

  • A degree in biochemistry, chemistry or engineering related discipline.
  • 6 years+ working knowledge in the biotechnology and/or pharmaceutical industry.
  • Demonstrated ability of Quality Management System tools and continuous improvement.
  • Demonstrating ability in leading a team.
  • Ability to work independently and effectively in a fast-paced environment delivering to a high quality standard.
  • Strong technical aptitude (ability to read & comprehend technical documentation and execute procedures) and demonstrated experience interfacing with regulators is desirable.
  • Established partnership, negotiation & conflict resolution skills.
  • Exceptional analytical, problem-solving & root-cause analysis skills.

To apply for this job email your details to patricia.arrue-elorza@Tandempm.ie.