Quality Validation Specialist

3 days ago


Darlington, United Kingdom CY Partner Full time

Quality Validation Specialist | £35,000 to £43,000 | Darlington

The Role
The focus of the Quality Validation Specialist is to assist in the development and implementation of the validation strategy for the qualification of the Biologics centre, Grand Challenge projects and their equipment to a current GMP compliant standard; this includes process utilities, process equipment and computer systems.
As a Quality Validation Specialist, you will 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.

Key Responsibilities
- To maintain consistent and documented compliance with all relevant Safety, Health and Environmental (SHE), quality and best practice requirements.
- To develop and implement validation policies, protocols, and standard operating procedures.
- Support the site Pharmaceutical Quality System including input into investigations and/or CAPAs.
- To work with the Biologics team, adopting a risk management approach with operations to define and implement the overall validation strategy
- Review and approval of risk assessments and validation documentation as required.
- To determine the overall Validation strategy for the implementation of the Development Work Packages for the required compliance to GMP
- To 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.
- To 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 both internal and external audits including writing reports, agreeing CAPA and following these up as required.

Key Skills Required
- Educated to degree level or significant experience in a related quality role
- Knowledge of GAMP, EU GMP Guidelines and Annexes 1, 2 & 15, 21 CFR Part 11.
- Experience of providing support for internal and external audits
- Will possess significant quality system and validation expertise and experience of operating within a GMP environment
- Will exhibit professional mastery of principles and practices in GMP quality systems, gained in industrial environments.
- Knowledge of ISO 9001 Quality Management System Standards.
- Experience in the use of Electronic Document Management systems and QMS.


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