Quality Lead / Qualified Person (QP)

by | Nov 12,

Quality Lead / Qualified Person (QP)

Company Background

HiTech Health focuses on enabling healthcare companies to develop, launch and supply products to the market. The company was established in 2013, bringing together an experienced and multi-disciplinary team from across the pharmaceutical, biotechnology and medical device industries. Operating internationally, HiTech Health supports companies to develop, manufacture and supply life-changing therapies to patients.

We are seeking to hire a Quality Lead / Qualified Person to support our rapidly growing business. This is an exciting role for a highly motivated individual to join a growing organisation and to be deeply involved in driving Quality Assurance and compliance activities within the company. The successful candidate will have the opportunity to work with a variety of clients and industry leading technologies to support the treatment of patients, including those suffering from rare and orphan diseases.

Role Description: Act in the capacity of a Qualified Person in accordance with EudraLex Volume 4, Annex 16, Directive 2001/83/EC and Clinical Trials Regulation (EU) No 536/2014 to support disposition of medicinal products.

Lead all of the  HiTech Health Quality and Compliance activities and promote continuous compliance and improvement of the Quality Management System.

Essential duties and responsibilities include, but are not limited to, the following:

As Qualified Person ( QP ) :

  • Ensures each batch of medicinal product has been manufactured and tested in accordance with the requirements of its Marketing Authorisation / Clinical Trial Authorisation / Product Specification
  • Ensures each batch has been manufactured and checked in accordance with the principles and guidelines of GMP
  • Review and approve batch manufacturing records and associated quality documentation to ensure compliance and product quality prior to release
  • Lead and contribute to root-cause analysis, investigations and risk assessments related to manufacturing deviations and changes and ensuring appropriate actions are implemented.
  • Provide oversight of sterile and aseptic manufacturing, contamination control, and environmental monitoring programs as it relates to product quality and disposition.

As Quality Lead:

  • Provide strategic and operational leadership of the Quality Assurance function, ensuring compliance with applicable GMP, GDP, regulatory and company requirements
  • Foster a culture of quality, compliance, continuous improvement, and patient safety while leading cross-functional collaboration across manufacturing, quality control, supply chain and technical operations.
  • Provide leadership and mentorship to all internal quality teams within the organisation to ensure high performance and engagement.
  • Manage the governance, compliance and continuous improvement of the Pharmaceutical Quality System
  • Establish and monitor departmental KPIs and quality metrics.
  • Provide Quality leadership and direction for equipment, aseptic process, cleaning, computerised systems, and facility validation/qualification programmes
  • Oversee document management, change control, deviations, CAPA, complaints, supplier quality management, training, and management review processes.
  • Participate in the internal and external audit programme; lead customer audits and regulatory inspections
  • Act as the primary quality contact for regulatory authorities, customers, suppliers, and external auditors
  • Ensure all regulated activities are performed in compliance with approved regulatory licenses

Requirements and Core Competencies:

  • A degree in Pharmacy, Pharmaceutical Science, Life Sciences, Engineering or a related discipline
  • Must be a Qualified Person (QP), eligible to certify batches within the EU/EEA
  • 8+ years in pharmaceutical quality roles within a GMP-regulated environment
  • 3+ years Quality leadership/supervision preferred
  • Hands-on aseptic / sterile manufacturing experience
  • Strong QA/GMP technical knowledge, with demonstrated capabilities to guide and support a growing organisation
  • Strong leadership and mentorship skills, with a demonstrated ability to guide and support teams
  • Demonstrated strong interpersonal skills, a flexible, collaborative and team-oriented approach to problem solving and an ability to work in a fast-paced environment

Location:

Ireland. Details to be discussed