Head of Quality

2 weeks ago

Dublin, Dublin City, Ireland TEAM HORIZON Full time

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Team Horizon - Head of Quality

Location: Midlands, UK

Team Horizon is seeking a Head of Quality for our client's manufacturing facility in the Midlands. In this role, you will oversee the Quality Assurance and Quality Control Teams, support the implementation, maintenance, and continual improvement of the company's QMS, and undertake the role of QP named on the relevant MIA(s).

Why you should apply:
  • Opportunity to work with a diversified portfolio of products across multiple therapeutic areas, including analgesics and anti-infectives.
  • Excellent chance to utilise QP eligibility and leadership experience in a Head of QA position overseeing Quality Assurance and Quality Control Teams.
  • Highly competitive salary and benefits package.
Key responsibilities:
  • Ensure an appropriate, compliant QMS is in place to meet site compliance, including regulator inspections, and optimize throughput.
  • Perform QP certification of products for market release, in line with business needs and schedule.
  • Manage site quality operations and batch certification activities, ensuring compliance and timely release.
  • Review batch documentation and certify products in accordance with GMP, MA, and legislation.
  • Communicate issues impacting release to management and supply chain.
  • Promote GMP, GDP, and QMS practices within the site, seeking continuous improvement.
  • Support investigations into non-conformances, complaints, recalls, and batch issues.
  • Review and approve QMS documentation related to quality activities.
  • Establish and monitor KPIs for quality activities and oversee site audit programs.
  • Coordinate complaint management and recalls.
  • Prepare for and support regulatory, company, and customer audits.
  • Implement and oversee training programs on QMS processes and SOPs.
  • Participate in management reviews and maintain accurate records of authorized activities.
  • Stay informed of applicable legislation and industry practices.
  • Perform additional tasks as assigned.
Qualifications:
  • Eligible to be named on a manufacturing license as a Qualified Person under EU Directive 83/EC or amendments.
  • Minimum of 5 years' experience in pharmaceutical quality management.
  • Strong organizational, communication, and project management skills, with proficiency in IT.

This job is active and accepting applications.

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