To assist with the definition and implementation of Operational Validation activities that ensure effective oversight of and verification that validation activities are in compliance with EU/FDA regulatory requirements.
Primary functions of the job are to:
Lead the Validation Support for Computerised System Validation (CSV) and Data Integrity (DI) Compliance including validation of new systems, periodic validation reviews and ensuring that Valneva electronic systems remain in compliance following changes to regulations.
Acting as subject matter expert in regulatory inspections of these areas. Support assay validation, process validation, shipping validation and equipment qualification in line with training and experience.
- Reporting to the Head of Validation (Scotland), participating and leading (where appropriate) the key site Validation projects representing the Validation department, with a key focus on Computerised System Validation.
- Maintain oversight of changes to regulatory guidelines, industry expectations and best practices.
- Provide guidance and training to ensure site-wide understanding of new and upcoming changes, including update to validation related procedures and concepts as appropriate to meet business needs.
- Assist in the development, definition and implementation of operational validation activities.
- To identify areas of improvement for validation systems/procedures and to provide support with the implementation of such improvements.
- Generate and/or perform reviews of validation documentation in accordance with relevant Standard Operating Procedures, including but not limited to:
- Validation Master Plan(s)/Validation Plans
- Validation Protocols
- Validation Reports
- Risk Assessments
- User Requirement Specifications
- Test scripts
- Support / lead data generation and risk assessment to set acceptance criteria and define the data requirements necessary to ensure that validation work is compliant.
- To ensure that the Head of Validation and other key stakeholders are informed of validation matters which may have an adverse impact on the validation status of facilities, equipment, systems, the manufacturing process on product disposition (e.g. batch/lot release decisions).
- Investigate and report Quality Issues, escalating to management as required.
- To compile key quality data for the validation program and to make such data available to management to drive a culture of continuous improvement that is fully compliant with current EU/FDA regulations and quality requirements and Valneva Scotland Ltd business needs.
- Be the Subject Matter Expert during internal/external and third-party audits.
- Maintain training in Equipment Qualification and Assay Validation and actively support the validation specialists.
Any other reasonable duties as requested by the Head of Validation (Scotland).
- Effective communication skills across all personnel levels and function areas
- Good working knowledge of Microsoft Office including Word, Excel, PowerPoint and Project
- A logical approach to problem solving
- Good organisational abilities
- Ability to operate with minimal direct supervision
Ability to train staff across all personnel levels and functional areas
- HND level or equivalent experience
- Working knowledge of validation within a GMP manufacturing environment
- More than 2 years Computerised System validation experience in a biopharmaceutical or pharmaceutical manufacturing environment
- Working knowledge of equipment, facility, assay or process validation.
- Experience as a validation subject matter expert (in the above topics) in regulatory inspections