The Validation Lead is a newly created role within the CDMO to support the business growth for GMP manufacturing and facility upgrade. You will be a critical member of the Quality Assurance team as a subject matter expert leading Touchlight's validation and qualification programs, 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 validation professional with the ability to lead site wide GMP validation and qualification approaches and primarily be responsible for implementing Touchlight's validation and qualification systems for facilities and equipment. Alongside this, you will be responsible for identifying Computerized System Validation requirements and be the site lead for Data Integrity and Data Governance programs. You will have a strong leadership profile. 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.
- Be the site wide SME for validation and qualification as it relates to facilities, utilities and equipment, including computerises system/software validation application.
- Determine Validation Master Plan and Validation Policy initiatives
- Develop and implement clinical phase appropriate validation and qualification systems.
- Manage and maintain those validation and qualification programs, identify re-validation criteria.
- Identify opportunities for improvement and implement those continuous improvement initiatives.
- Make assessment on the requirements of supporting systems to validation and qualification.
- Participate in the quarterly Quality Management Review meetings
- Recruit, manage and optimise the performance of a Validation team.
- Apply Quality Risk Management throughout the validation and qualification systems.
- Support on approaches to analytical method validation, cleaning validation and process validation with other SMEs
- Work closely with colleagues in the QA, Compliance, Regulatory, Operations and Development departments
- Report to the Group Head of QA on monthly performance
- A proven recent track record of setting up, leading, and performing validation and qualification programs.
- A minimum of 5 years’ experience working in the validation field for a GMP and/or GLP regulated environment.
- Requirement to have worked for a CDMO at all stages of product development.
- Strong knowledge of Data Integrity requirements as they relate to GxP environments.
- Knowledge of core QA systems, such as Quality Events, Deviations, CAPA and Change Management
- Knowledge of quality risk management, root cause analysis and FMEA processes
- Awareness of regulatory requirements for GMP
- 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 "Validation Lead”
Due to the high number of applicants, we will only contact those who we invite to interview.