Technical Writer - Pharmaceutical

About the role

We are looking for an experienced Technical Writer to author and maintain IT Standard Operating Procedures and related controlled documents in a GxP-regulated pharmaceutical environment. You will work with IT Operations, Infrastructure, Security, Application Support, Computer System Validation and Quality Assurance to document how GxP computerised systems and the IT services behind them are run, controlled and kept in a validated state. Your procedures will need to be usable by engineers day to day and still hold up under regulatory inspection.

Key responsibilities

• Author, review and update IT SOPs, work instructions, qualification documentation and templates covering areas such as:
• IT change management and release management
• Incident, problem and service request management
• Backup, restore and archiving
• Business continuity and disaster recovery
• Patch and vulnerability management
• Configuration management
• Audit trail review
• IT supplier and cloud service provider management

• Make sure IT procedures meet regulatory expectations, especially 21 CFR Part 11, EU GMP Annex 11, the MHRA GxP Data Integrity Guidance and GAMP 5 (Second Edition).
• Document the controls that keep GxP systems in a validated state across their life cycle, from commissioning through periodic review to decommissioning and data migration.
• Apply ALCOA+ data integrity principles to procedures for electronic records, electronic signatures, audit trails and system administration.
• Align IT SOPs with ITIL-based service management practices and the organisation's ITSM tooling (eg ServiceNow).
• Work with Information Security to document security controls consistent with frameworks such as ISO 27001, NIST CSF or Cyber Essentials.
• Manage documents through their full life cycle in the EDMS: drafting, review routing, approval, effective dating, periodic review and retirement.
• Harmonise Legacy IT documentation by consolidating overlapping procedures, separating GxP from non-GxP scope, and applying a consistent structure and style.
• Support regulatory inspections, internal audits and supplier audits by preparing IT document packs and responding to documentation queries.
• Work with Training so that IT staff are trained on new and revised SOPs, with records kept.

Essential skills and experience

• At least 3 years' experience writing controlled documentation in the pharmaceutical, biotech or medical device industry, with at least part of that focused on IT or computerised systems.
• Proven experience writing IT SOPs or IT quality procedures in a GxP environment.
• Solid working knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5 and data integrity expectations for computerised systems.
• Good understanding of IT service management processes; ITIL Foundation or equivalent experience is expected.
• Enough technical literacy to discuss infrastructure, cloud (IaaS/PaaS/SaaS), identity and access management, and backup architectures with engineers, and to document them accurately.
• Experience with IT change control, CAPA and deviation processes.
• Hands-on use of an EDMS such as Veeva Vault QualityDocs, MasterControl or OpenText Documentum, and an ITSM tool such as ServiceNow.
• Excellent written English, with the ability to turn technical detail into clear, unambiguous steps.
• Confidence in challenging subject matter experts when procedures don't match actual practice.

Desirable

• Degree in computer science, information systems, life sciences or a related discipline.
• CSV or Computer Software Assurance (CSA) experience, including validation plans, URS, risk assessments and periodic review reports.
• Familiarity with ICH Q9 (Quality Risk Management) and ICH Q10 (Pharmaceutical Quality System).
• Experience documenting cloud and SaaS controls, including supplier qualification and shared responsibility models for GxP systems.
• Experience supporting MHRA, FDA or EMA inspections involving computerised systems.
• ITIL 4 certification, ISO 27001 awareness, or a technical writing qualification (ISTC/STC).
• Process mapping skills in Visio, Lucidchart or BPMN.

Personal attributes

You are comfortable in two worlds: talking backups and access provisioning with infrastructure engineers, and data integrity and validated state with QA. You are methodical and pragmatic. You care that an IT SOP reflects what really happens at 2am during an incident, not just what looks good in an audit.