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 to help support the production of dbDNA as a critical starting material for ATMP production and as an Active Pharmaceutical Ingredient.
You will be an experienced QA professional with strong knowledge of core QA systems; Quality Events and Deviations, CAPAs, Change Management, Root Cause Analysis, Risk Assessments, Self-inspections, Batch Review, Training and Document Control. The Senior QA Officer reports to the QA Manager, and in support of the Group Head of QA, to ensure adherence to Touchlight’s Quality Management Systems. 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.
- As a Senior team member, have the ability to support, mentor and teach across other business functions in core QA activities.
- Deliver QA training initiatives across the Touchlight business.
- Enforce Quality Policies and objectives throughout QA.
- Identify opportunities for improvement and implement those continuous improvement initiatives.
- A holistic approach to quality risk management, root cause analysis and FMEA processes and how this is applied throughout the lifecycle of a product.
- Support and deputise for the QA Manager for QA activities, where necessary.
- Prepare QA KPIs in support of the quarterly Quality Management Review meetings
- Manage and maintain the Documentation and Training Systems.
- Work closely with colleagues in the Compliance, Validation, Regulatory, Operations and Development departments
- A strong knowledge of GMP Quality Management Systems
- A minimum of 3 years’ experience working in a senior QA function role.
- Requirement to have worked for a CDMO at all stages of product development.
- Strong experience with leading other business functions through quality event management, deviations and CAPA programs
- Strong experience in change control procedures.
- Experience in leading and handling complaints, returns and recall.
- Working knowledge of regulatory requirements related to GMP.
- Experience in participating in client and regulatory audits and supporting other business functions with applying appropriate CAPAs.
- Experience in internal and external auditing of vendors to support the compliance function of QA.
- Experience using electronic Quality Management Systems is desirable.
- Experience in supporting validation and qualification programs and related data integrity principles.
- Strong knowledge and proven ability with quality risk management, root cause analysis and FMEA processes
- Strong IT, multitasking and communication skills.
- Confidence to challenge and simplify existing systems & processes.
- A self-starter, with a desire to meet targets and drive success.
- Innovative, pragmatic, team-focused and customer-oriented in personality.
- BA/BSc or equivalent educational background.
Applicants MUST be eligible to work in the UK.
Apply for this role by emailing a CV and cover letter to email@example.com clearly stating the reference "Senior QA Officer”
Due to the high number of applicants, we will only contact those who we invite to interview.