OGT is a leading global provider of clinical and diagnostic genomic solutions. We believe in creating products and partnerships that enable clinicians to deliver personalised healthcare to patients and that empower clinical researchers to develop the next generation of precision medicines.
** This is a 6 month fixed-term contract position **
The Technical Writer is responsible for creating, maintaining, and managing documentation related to the validation of Enterprise Resource Planning (ERP) and Manufacturing Resource Planning (MRP) software systems. This role requires a strong understanding of software validation principles, regulatory requirements, and ERP/MRP systems, as well as exceptional writing and communication skills. The Technical Writer will collaborate with cross-functional teams, including IT, Quality Assurance, and business stakeholders, to ensure that all validation documentation is accurate, complete, and compliant.
What you'll be doing for us
- Validation Documentation:
- Develop, write, and revise validation documentation, including validation plans, protocols (IQ, OQ, PQ), summary reports, and traceability matrices.
- Create and maintain documentation in accordance with company standards, regulatory guidelines, and industry best practices. Such as FDA 21 and GAMP 5.
- Ensure that all documentation is clear, concise, accurate, and easily understood by the target audience.
- Develop, write and revise work instructions and SOPs.
- Collaboration and Support:
- Work closely with IT, Quality Assurance, and business teams to gather information, define requirements, and ensure that documentation accurately reflects the validated state of the ERP and MRP system.
- Collaborate with subject matter experts (SMEs) to obtain technical information and ensure the accuracy of documentation.
- Provide support and guidance to project teams on documentation requirements and best practices.
- Documentation Management:
- Manage the storage, organization, and version control of validation documentation.
- Ensure that all documentation is readily accessible, retrievable, and maintained in a controlled environment.
- Utilize document management systems to streamline the documentation process and ensure compliance.
- Compliance and Quality:
- Ensure that all documentation complies with relevant regulations, standards, and company policies.
- Participate in audits (internal and external) and inspections related to ERP software validation.
- Contribute to the development and improvement of documentation templates, processes, and standards.
- ERP System Knowledge:
- Develop a strong understanding of the ERP system's functionality, architecture, and underlying technology.
- Stay up to date with changes, upgrades, and new releases of the ERP system and ensure that documentation is updated accordingly.
What we are looking for in you
Essential
- Demonstrated ability to understand ERP and MRP systems and software
- Comprehensive understanding of software validation within a GxP environment
- Excellent written communication skills, including the ability to create clear, concise, and accurate technical documentation.
- Effective verbal communication skills for collaborating with suppliers and internal stakeholders.
Desirable
- Familiarity with life science manufacturing processes and relevant regulations and standards
- Understanding of Sage 200 Professional
- Understanding of CIM200
- Experience working with electronic Quality Management Systems (eQMS), particularly in the context of creating and managing technical documentation.
In return you'll receive:
- Competitive salary
- Pension Scheme (10% non-contributory)
- Group Income Protection
- Group Life Assurance
- Prorata of 25 days holiday plus UK bank holidays
- High Street Discount Scheme.
Application is via CV and a one-page covering letter outlining your suitability for the role, salary expectations and notice period.
Please note that we will need to establish your right to work during the recruitment process.
