Software QA Specialist

Experience Dependent
24 Oct 2019
21 Nov 2019
Rhys Evans
Contract Type
Full Time
We are currently looking for a Software QA Specialist to join a leading Clinical Diagnostics company based in the London area. As the Software QA Specialist, you will be responsible for ensuring the Verification, Validation and Life Cycle Management of Software is compliant and in a timely manner.


Your duties as the Software QA Specialist will be varied. However, the key duties and responsibilities are as follows:

1. You will ensure review, update and approve Software Life Cycle Procedures and Policies, including the Verification and Validation (V&V), whilst acting as the SME in this area and providing training to staff.

2. As the Software QA Specialist, you will review and approve Software Development and Validation documentation, such as User Requirement Specifications (URS), Technical Specifications, Test Protocols and Scripts, and Verification and Validation (V&V) protocols and reports. This will also see you presenting this documentation during client and regulatory audits.

3. You will raise and investigate deviations, implement effective CAPAs and Change Controls, prepare KPIs for the maintenance and improvement of the company's management system and management reviews.

4. As the Software QA Specialist, you will support Information and Cyber Security Compliance, implement Information Security and Privacy objectives, perform internal audits, and qualify and approve software and technology suppliers.


To be successful in your application to this exciting opportunity as the Software QA Specialist, we are looking to identify the following on your profile and history:

1. Experience of Software / Systems Validation ( GAMP / Annex 11 ) in the pharmaceutical or medical device industries, or other software industry.

2. Proven industry experience in writing and reviewing Software Development and Validation documentation.

3. A working knowledge and practical experience with GCP / ISO13485 / ISO27001 regulations and Information System Security and Privacy / GDPR.

Key Words: QA | Quality Assurance | CSV | Computer Systems Validation | Software Validation | GAMP | GAMP5 | Annex 11 | Biotechnology | Medical Devices | IT QA | Software Quality Assurance | GCP | ISO13485 | ISO27001 | Internal Audits | Supplier Management | Supplier Qualification | Regulatory Inspections | Compliance | Validation Protocols | Diagnostics

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment professionals and scientists. We look forward to helping you with your next career moves.