Quality Validation SpecialistApply Now
At CPI we work with our partners to translate inventions into products and processes that enhance health and well-being, protect and improve our environment and increase productivity across industries.
With a deep understanding of innovation processes and funding, outstanding technical expertise and industry relevant assets, we enable products and processes to be quickly and cost-effectively brought to market. This supports the development of next-generation manufacturing, highly-skilled jobs and economic growth for the UK.
Our partners operate across many diverse markets including pharmaceuticals, speciality chemicals, food and drink, electronics and transportation.
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Why this role is important for CPI’s work
CPI has a newly created opportunity for an experienced Quality Validation Specialist to join the growing Biologics Quality team, based in Darlington. The Quality team ensure a robust QMS is in place to achieve quality standards and to comply with regulatory compliance and QMS standards. The team have recently implemented GMP QMS processes, delivered GMP training and are working with external organizations, including MHRA.
Reporting to the Quality Manager Biologics, the Quality Validation Specialist will be responsible for validation of Biologics GMP facilities, utilities, equipment and projects. Working with the wider quality and validation teams across CPI to ensure validation strategy is met. CPI work with many customers across a range of projects, therefore in this role, you will be exposed to a wider range of experience than other manufacturing organisations. You will also have the opportunity to be involved with internal projects which will add further variety to the role.
The focus of this role is to assist in the development and implementation of the validation strategy for the qualification of the CPI Biologics RNA Centre of Excellence, Grand Challenge projects and their equipment to a current GMP compliant standard; this includes process utilities, process equipment and computer systems. To deliver and maintain compliance to a GMP standard and specifically to the requirements of Annexes 11 & 15 of EudraLex Volume 4 and taking into account ICH Q9 and ISPE Codes/Guides.
Read about the RNA Centre of Excellence here: www.uk-cpi.com/news/new-rna-centre-of-excellence
Maintain consistent and documented compliance with all relevant Safety, Health and Environmental (SHE), quality and best practice requirements.
Develop the RNA Centre of Excellence’s validation philosophy and approach.
Develop and implement validation policies, protocols and standard operating procedures.
Work with the Biologics team, adopting a risk management approach with operations to define and implement the overall validation strategy for the RNA Centre of Excellence.
Review and approve the validation and qualification activities associated with: the facility qualification and its utility systems; the establishment of the process equipment; and with ongoing operations.
Work with the Grand Challenge Teams to determine the overall Validation strategy for the implementation of the Development Work Packages so that the required compliance to GMP is planned and enabled during GC definition and equipment/facility specification and then carried forwards through procurement, installation, commissioning and into operations.
Work closely with the Biologics Team so that information, protocol and performance requirements are correctly specified and with contractors, engineers and vendors of facility, utility and equipment items so that these requirements are correctly delivered to enable initial and continued compliance.
Work effectively and supportively with the Biologics project team members to deliver the development phase activities and the Facility in accordance with the programme, budgets and design intent.
Coordinate with the Biologics Project Team on any future facility build projects to engage with external stakeholders (including the MHRA) to ensure that innovative Biologics concepts are viable within current GMP regulation.
Support the site Pharmaceutical Quality System including input into investigations and/or CAPAs.
Support both internal and external audits including writing reports, agreeing CAPA and following these up as required.
Review and approval of risk assessments and validation documentation as required.
Keep self up to date with external developments in areas of specialism, and/or legislative, quality and SHE-related changes, ensuring application of new best practice and/or knowledge.
The person we are seeking
You will be educated to a minimum of HNC or Foundation Degree level (or equivalent) in a Scientific/Engineering discipline and will hold significant industrial experience.
You will be able to demonstrate knowledge of GAMP, EU GMP Guidelines Annexes 1, 2 & 15, 21 CFR Part 11.
Experience in providing support for internal and external audits is essential.
Significant quality system and validation expertise and experience of operating within a GMP environment, developing and implementing and monitoring quality systems and validation programmes, are essential for this role.
You will also exhibit professional mastery of principles and practices in GMP quality systems, gained in industrial environments.
You must be able to demonstrate the ability to work in a fast-paced environment, flexibility to adjust with moving priorities and ensuring attention to detail remains first class.
Can demonstrate evidence of knowledge sharing and network building practice across teams or groups.
Has the ability to apply theoretical and practical quality tools and techniques to contribute to business activities.
Can provide examples of actively utilising cross-team collaboration to achieve desired results.
Has the confidence to use own judgement and initiative within standard quality practices, as well as an understanding of when to seek advice from colleagues.
Membership of a relevant professional body.
Knowledge of ISO 9001 Quality Management System Standards.
Knowledge of EU GMP Guidelines including Annexes 1, 2 & 15.
Experience in the use of Electronic Document Management systems and QMS.
What does CPI offer you?
At CPI, we offer a wide range of benefits to our employees, this includes:
- Up to 36 days holiday, including bank holidays – Plus a holiday purchasing scheme
- Generous pension scheme
- Life assurance and accident insurance schemes
- Flexible working
- Learning and Development Opportunities
- Free parking
Find out more about our culture and benefits.
CPI is an organisation based in the UK. Commencement of employment is conditional to demonstrating right to work in the UK, sponsorship may be available.