Career opportunity: Senior QA Officer

Senior QA Officer

Touchlight is currently seeking an experienced Senior QA Officer to join its Quality Unit as part of the Touchlight DNA Services CDMO company. The Senior Quality Assurance Officer is responsible for maintaining the Quality Assurance (QA) department functions, in compliance with the EU GMP Part II (ICH Q7) Quality Management System and demonstrating compliance through Good Manufacturing Practice (GMP) principles. This is an exciting, fast-paced environment suited to self-motivated, organised, conscientious and highly accurate individuals, who can contribute to and successfully work in a multi-talented and compliance orientated team.

In addition to working at the forefront of DNA research in a dynamic biotech company, the successful candidate will receive a competitive salary, a company performance related bonus, and be eligible to join the company pension scheme, among other benefits.

Role description:

This is an operational Quality role. There will be close working with the CMC-Development, Production, Continuous Improvement and Business Development Teams to support on-going project and product needs. Key systems in Quality Assurance will include; Quality Events and Deviations, CAPAs, Root Cause Analysis, Risk Assessments, Self-inspections, Internal and External Auditing, Batch Review, Validation and Qualification, Change Control, Training, Data Integrity, Document Control, Complaints and Continuous Improvement initiatives.

The Senior QA Officer reports to the QA Manager, and in support of the Head of Quality, to ensure regulatory requirements are met. This is an operational role. There will also be close working with the CMC-Development, Continuous Improvement and Business Development Teams to support on-going project and product needs.

Qualifications and experience:

  • Applicants should have a Degree level qualification in a biological science discipline
  • You will have a minimum of 2 years’ experience working in a GMP and/or GLP regulated environment
  • Strong knowledge of Quality Management Systems
  • Experience using electronic Quality Management Systems
  • Experience in coordinating validation and qualification programs
  • Experience with quality event management and CAPA programs
  • Experience of change control procedures
  • Experience in handling complaints, returns and recall
  • Experience in quality risk management, root cause analysis and FMEA processes
  • Working knowledge of regulatory requirements
  • Working towards a Qualified Internal and External Auditor status
  • Experience in hosting regulatory and customer audits
  • Knowledge of approaches to data integrity
  • Ability to challenge data quality for release purposes
  • Developing Continuous improvement initiatives
  • Experience of self-inspection and Internal auditing programs

All candidates should possess clear communication and presentation skills and an ability to work effectively as an individual and in a team environment. Successful candidates will also be proficient in organising and managing their work and delivering results to established timelines.

Applicants MUST be eligible to work in the UK.

Apply for this role by emailing a CV and cover letter to clearly stating the reference "SENIOR QA OFFICER". Closing date for applications is 30th April 2021.

Due to the high number of applicants, we will only contact those who we invite to interview.