GMP Compliance Specialist

20 hours ago


Solihull, Solihull, United Kingdom Touchlight Full time
Quality Assurance Manager Job Summary:

Touchlight is seeking a Quality Assurance Manager to support our growth phase. The successful candidate will have a strong background in GMP quality management and experience working in a fast-paced Contract Development Manufacturing Organisation (CDMO) environment.

About the Company:

Touchlight is pioneering the Synthetic DNA market, with a focus on enzymatic synthesis of novel DNA formats. Our technology is built on the conviction that DNA is fundamental to the future of medicine.

About the Role:

The Quality Assurance Manager is responsible for maintaining compliance with EU GMP Part II (ICH Q7) Quality Management System and demonstrating compliance through Good Manufacturing Practice (GMP) principles. This is an operational QA role, requiring close working with various teams, including Compliance, Validation, CMC-Development, Production, Continuous Improvement, and Commercial Teams.

Responsibilities:
  • Maintaining compliance with EU GMP Part II (ICH Q7) Quality Management System
  • Demonstrating compliance through Good Manufacturing Practice (GMP) principles
  • Leading the Quality Assurance department functions
  • Collaborating with various teams to support ongoing project and product needs
Requirements:
  • Expert knowledge of GMP Quality Management Systems
  • Minimum 7 years' experience working within QA, with at least 2 years in a QA Manager position
  • Experience working for a CDMO at all stages of product development
  • Knowledge of core QA systems, such as Quality Events, Deviations, CAPA, and Change Management
  • Working knowledge of regulatory requirements related to GMP
Compensation:

$90,000 - $120,000 per annum



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