Our client is a rapidly growing speciality vaccine company based in Scotland, due to success and progression of the company they are looking to recruit a number of Validation Specialists to join them at this important stage of growth. You will provide support and advice for required validations on site and act as subject matter expert in regulatory inspections.
You will be responsible for:
- Reporting to the Head of Validation, assist in the operational validation activities, including physically performing Equipment and Facility Qualifications.
- Identify areas of improvement for validation systems/procedures and to provide support with the implementation of such improvements.
- Generate and complete validation documentation in accordance with relevant Standard Operating Procedures, including but not limited to:
- Validation Plans, protocols and reports
- Participate in project groups and 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.
- To keep up to date with current guidelines and regulatory requirements in respect of internal and external quality requirements.
- To provide and/or coordinate training in validation related procedures/concepts as appropriate to meet business needs.
- Provide support during internal/external and third-party audits.
- Any other reasonable duties as requested by the Head of Validation Scotland.
Education / Experience:
- HND level or equivalent qualification in relevant subject (required).
- Working knowledge of Equipment Qualification and/ or Facility Qualification in a biopharmaceutical or pharmaceutical GMP environment (required).
- Working knowledge of validation principles in at least one of the following (preferred):
- Validation of aseptic processes (including filling),
- Validation of Computerised systems,
- Process Validation,
- Assay Validation,
- Cleaning Validation.
- Experience in regulatory inspections (preferred).
- Effective communication skills across all personnel levels within the organisation and with contractors / external engineers.
- Good Writing skills for completion of documentation and report writing.
- Good working knowledge of Microsoft Office including Word, Excel and PowerPoint.
- A logical approach to problem solving
- Good organisational and effective prioritisation skills
- Ability to operate with minimal direct supervision
The company will offer a competitive salary plus an excellent benefits package and flexible working patterns.