Negotiable
Undetermined
Remote
United Kingdom
Summary: This role is for IT QA Executives & Professionals based in the UK or EU, focusing on maintaining regulatory compliance for digital operations within the healthcare and pharmaceutical sectors. Responsibilities include conducting audits, providing consultancy, and ensuring effective quality management strategies. The position requires extensive experience in quality auditing and digital compliance. Candidates must be able to work remotely or on-site in an international environment.
Key Responsibilities:
- Digital Compliance Consultancy
- Complex Digital Health Provider Audits
- eGxP Audits (eGCP/eGVP/eGCLP)
- Gap Analysis
- Strategic Audit Program Design
- Computer System Validation Services
- Vendor Oversight Strategy
- Enterprise Risk Management
- Quality Risk Management Strategy
- Inspection Readiness Strategy
- Inspection Preparation & Hosting
- ISO27001 Information Security Management System Consultancy
- Digital Quality Training
- Post Inspection Response and Remediation
- Leadership & Auditor Coaching
- Departmental Redesign
- In-house QA support
Key Skills:
- 7+ years of experience as IT QA Auditor, Professional or Validation Engineer
- Experience in Quality Auditing, Consultancy, and Training Services to the Healthcare, Pharmaceutical, Medical Devices and Veterinary market sectors
- Experience in Digital Compliance Consultancy, eGxP Audits (eGCP/eGVP/eGCLP), Gap Analysis, Strategic Audit Program Design, Computer System Validation Services, Vendor Oversight Strategy
- Knowledge of Enterprise Risk Management, Quality Risk Management Strategy, Inspection Readiness Strategy, Inspection Preparation & Hosting, ISO27001 Information Security Management System Consultancy, Digital Quality Training, Post Inspection Response and Remediation
- Excellent communication and analytical skills
- Ability to work remotely or on site in an international environment
Salary (Rate): undetermined
City: undetermined
Country: United Kingdom
Working Arrangements: remote
IR35 Status: undetermined
Seniority Level: undetermined
Industry: IT
Company Description Digital Quality Associates (DQA) provides comprehensive Quality Auditing, Consultancy and Training Services to the Healthcare, Pharmaceutical, Medical Devices and Veterinary market sectors. DQA offers an end to end bespoke and flexible compliance service to ensure efficient, effective, and regulatory compliant business operations. DQA has a remote services offering and expertise to help organisations adapt their business processes and operations whilst maintaining regulatory compliance.
Role Description This is a permanent role for an EU and US Based IT QA Executives & Professionals. The role involves maintaining regulatory compliance for digital operations. The day-to-day tasks include Digital Compliance Consultancy, Complex Digital Health Provider Audits, eGxP Audits (eGCP/eGVP/eGCLP), Gap Analysis, Strategic Audit Program Design, Computer System Validation Services, Vendor Oversight Strategy, Enterprise Risk Management, Quality Risk Management Strategy, Inspection Readiness Strategy, Inspection Preparation & Hosting, ISO27001 Information Security Management System Consultancy, Digital Quality Training, Post Inspection Response and Remediation, Leadership & Auditor Coaching, Departmental Redesign, and In-house QA support This role is based in the UK or EU, please do not apply if outside of these regions as your application will not proceed.
Qualifications 7+ years of experience as IT QA Auditor, Professional or Validation Engineer Experience in Quality Auditing, Consultancy, and Training Services to the Healthcare, Pharmaceutical, Medical Devices and Veterinary market sectors Experience in Digital Compliance Consultancy, eGxP Audits (eGCP/eGVP/eGCLP), Gap Analysis, Strategic Audit Program Design, Computer System Validation Services, Vendor Oversight Strategy Knowledge of Enterprise Risk Management, Quality Risk Management Strategy, Inspection Readiness Strategy, Inspection Preparation & Hosting, ISO27001 Information Security Management System Consultancy, Digital Quality Training, Post Inspection Response and Remediation Excellent communication and analytical skills Ability to work remotely or on site in an international environment