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 ..... full job details .....