FREE ACCESS
5,000–10,000 jobs/day
See all jobs on Scoutfield
Search thousands of fresh jobs every day.
Discover
- Fresh listings
- Fast filters
- No subscription required
Create a free account and start exploring right away.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in writing and managing IT SOPs and quality procedures within GxP environments, ensuring compliance with regulatory standards such as 21 CFR Part 11 and EU GMP Annex 11. Proficient in IT service management processes and document management systems, with a strong focus on data integrity and audit readiness.
Highest-signal resume keywords
IT SOP WritingGxP ComplianceITIL FoundationEDMS ExperienceData Integrity Management
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Controlled DocumentationChange ManagementBackup ArchitectureCloud Services (IaaS/PaaS/SaaS)Configuration ManagementAudit Trail ReviewCAPA ProcessesRisk AssessmentsValidation PlansProcess Mapping
Soft Skills
Excellent Written EnglishConfidence in Challenging Experts
Tools & Technologies
ServiceNowVeeva Vault QualityDocsMasterControlOpenText Documentum
Certifications & Qualifications
ITIL 4 CertificationISO 27001 AwarenessTechnical Writing Qualification
Industry Keywords
21 CFR Part 11EU GMP Annex 11GAMP 5MHRA GxPICH Q9ICH Q10
Tech Stack
Tools & technologiesCloudITSMServiceNowVault
About the role
Key responsibilities & impact- Author, review and update IT SOPs, work instructions, qualification documentation and templates
- Cover IT change and release management, incident/problem/service request management, backup/restore/archiving, business continuity/disaster recovery, patch/vulnerability management, configuration management, audit trail review, and IT supplier/cloud service provider management
- Ensure IT procedures meet 21 CFR Part 11, EU GMP Annex 11, MHRA GxP Data Integrity Guidance and GAMP 5 expectations
- Document controls that keep GxP systems validated across commissioning, periodic review, decommissioning and data migration
- Apply ALCOA+ principles to electronic records, signatures, audit trails and system administration procedures
- Align IT SOPs with ITIL-based service management and ITSM tooling such as ServiceNow
- Document information-security controls aligned with ISO 27001, NIST CSF or Cyber Essentials
- Manage documents through the EDMS lifecycle, including drafting, review routing, approval, effective dating, periodic review and retirement
- Harmonise legacy IT documentation and separate GxP from non-GxP scope
- Support regulatory, internal and supplier audits by preparing document packs and responding to queries
- Work with Training to ensure IT staff are trained on new and revised SOPs and training records are maintained
Requirements
What you’ll need- At least 3 years' experience writing controlled documentation in the pharmaceutical, biotech or medical device industry, with at least part 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 GMP 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
- Technical literacy covering infrastructure, cloud (IaaS/PaaS/SaaS), identity and access management, and backup architectures
- Experience with IT change control, CAPA and deviation processes
- Hands-on use of an EDMS such as Veeva Vault QualityDocs, MasterControl or OpenText Documentum
- Experience with an ITSM tool such as ServiceNow
- Excellent written English
- Confidence challenging subject matter experts when procedures do not match actual practice
- Desirable: degree in computer science, information systems, life sciences or a related discipline
- Desirable: CSV or Computer Software Assurance experience, including validation plans, URS, risk assessments and periodic review reports
- Desirable: familiarity with ICH Q9 and ICH Q10
- Desirable: experience documenting cloud and SaaS controls, supplier qualification and shared responsibility models for GxP systems
- Desirable: experience supporting MHRA, FDA or EMA inspections involving computerised systems
- Desirable: ITIL 4 certification, ISO 27001 awareness, or a technical writing qualification (ISTC/STC)
- Desirable: process mapping skills in Visio, Lucidchart or BPMN
Benefits
Comp & perks- Flexible, family-friendly working
- Commitment to internal mobility and career progression
- Culture rooted in diversity, equality, inclusion & belonging