Touchlight is currently seeking an experienced QA Officer to join its Quality Unit as part of the Touchlight DNA Services CDMO company. The 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.
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 QA Officer reports to the QA Manager, and in support of the Head of Quality, to ensure regulatory requirements are met. 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:
- A Degree level qualification in a biological science discipline desirable
- Working knowledge of working within a GMP and/or GLP environment
- Working knowledge of Quality Management Systems
- Experience of electronic Quality Management Systems
- Experience with quality event management and CAPA programs
- Experience of change control procedures
- Knowledge of handling complaints, returns and recall
- Knowledge of quality risk management, root cause analysis and FMEA processes
- 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 firstname.lastname@example.org clearly stating the reference "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.