Touchlight is currently seeking an experienced Validation Lead to join its Quality Unit as part of the Touchlight DNA Services CDMO company. The Validation Lead will be responsible for leading the site wide GMP Validation and Qualification program. 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.
As the site Lead for Validation and Qualification activities, the role includes maintaining the Facility, Utilities and Equipment Qualification activities and maintaining the existing Asset Register along with associated coordination of Service Providers. Alongside this, they will be responsible for identifying Computerized System Validation requirements and be the site lead for Data Integrity and Data Governance programs. Support on Analytical Method validation as it relates to regulatory needs is desirable. They be key in identifying compliance requirements for Process Validation and Cleaning Validation.
The Validation Lead reports to the Head of Quality to ensure regulatory requirements are met, however they will also be working closely with the Head of Production to maintain the compliance with the EU GMP Part II (ICH Q7) Quality Management System and demonstrating compliance through Good Manufacturing Practice (GMP) principles. 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
- A minimum of 2 years’ experience working in a GMP and/or GLP regulated environment
- Strong knowledge of Qualification and Validation Systems, including Data Integrity requirements as they relate to GMP
- Experience in setting up, coordinating and performing validation and qualification programs
- 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
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 email@example.com clearly stating the reference "Validation Lead” 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.