Job Reference: J5631783
Updated On: 12/08/2019
Status: Under Offer
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Role OverviewWe are currently looking for a Software QA Manager to join a leading biotech/pharmaceutical software company based in the London area. As the Software QA Manager you will be responsible for ensuring all software produced is compliant to pharmaceutical qualifications such as current GCP, ISO13485, FDA QSR Part 820/Part 11, ISO27001
Key Duties and ResponsibilitiesYour duties as the Software QA Manager will be varied however the key duties and responsibilities are as follows:
1. As the Software Quality Assurance (QA) Manager supports the compliant and timely design/development, testing, verification, validation, configuration and life cycle management of software developed,
2. You will provide support to the drafting, review & approval of software development and validation policies and procedures; ensuring best practice for ‘security & privacy by design’ principles and compliance with current GCP, ISO13485, FDA QSR Part 820/Part 11, ISO27001 and regulatory & quality system requirements.
3. You will work with the software teams including Technical, R&D and Operations staff to review, update and approve policies, procedures, work instructions and forms relating to all aspects of the software life cycle, including verification and validation
4. The Software QA Manager will review and approve for Quality applicable software development & validation documentation, such as User Requirement Specifications, Technical Specifications, Test Protocols/Scripts, Verification and Validation protocols and reports.
Role RequirementsTo be successful in your application to this exciting opportunity as the Software QA Manager we are looking to identify the following on your profile and past history:
1. You must have SDLC knowledge from within a pharmaceutical company either internally or as a consultancy
2. You will need experience of software validation (e.g. GAMP/Annex 11) gained within a regulated industry i.e. pharmaceutical/medical devices, or other software critical organisation.
3. Educated to at least degree level (B.Sc. in Computer Science, Mathematics or technical/life science subject) or, alternatively relevant industry experience
Key Words: QA, Software, GAMP, GLP, Quality, FDA, GCP
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