Senior Quality Assurance Specialist (GMP)

Location Hertfordshire
Discipline: Regulatory Affairs
Job type: Permanent
Salary: £Salary: Competitive
Contact name: Katie Dunbar

Contact email:
Contact phone: 01293 584300
Job ref: 20872
Published: 30 days ago
Expiry date: 11 April 2021

​RBW are working on behalf of an international biotechnology company who focus on gene therapy to offer life-changing cures to people suffering from chronic diseases.

They have a requirement for a Senior QA Specialist , who will provide GMP support to manufacturing operations.

Role Functions:

  • Review draft and executed batch manufacturing records (BMRs) for compliance with GMP

  • QA approval of manufacturing PPM and calibration activities

  • Approve room release checks prior to manufacturing activities

  • Compile and maintain Product Specification Files (PSFs)

  • Review facility EM trends for approval by QA Manager (GMP) – viable/ non-viable, temperature/ humidity and differential pressures

  • Deputise for QA Manager (GMP) as required, where appropriate

  • Perform internal audits of GMP manufacturing activities and participate in external audits

  • Primary point of QA contact for all GMP deviations and change control assessments

  • Witnessing receipt of biological raw materials, approve/ reject raw materials for use in manufacturing

  • Lead validation / qualification activities as directed by QA Manager

Technical Qualification Requirements:

  • Educated to Degree level or equivalent

  • At least 5 years in GMP QA role, at least 2 of which must be in Biologics/Advanced Therapies/Cell therapies

  • Leading role in validation activities

  • Demonstrable Knowledge of current manufacturing processes/techniques

  • Thorough understanding of QA principles, especially non-conformance, change control and CAPA systems

Personal Skill Requirements:

  • Excellent planning and organisational skills

  • Ability to work in a small team in a dynamic environment

  • Significant experience with MS Office (specifically Word and Excel)

  • Excellent interpersonal skills

The role will be a mix of home working and office time in Hertfordshire. If you are interested in this position and would like to find out more, please get in touch for more information. You can contact Katie Dunbar on +44 (0) 1293 584 300 or use the apply button on this page.

Salary: Competitive