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- Tasks: Lead testing strategies and ensure compliance with GAMP5 standards.
- Company: Join Barrington James, a leader in consulting for regulated industries.
- Benefits: Enjoy flexible working options with potential contract extensions.
- Why this job: Make an impact in the pharma and biotech sectors while enhancing your skills.
- Qualifications: 3+ years in QA/testing with a degree in a technical field required.
- Other info: Work on-site or hybrid in Oxford, with opportunities for professional growth.
The predicted salary is between 40000 - 60000 £ per year.
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Role: Test Manager (GAMP5 Compliant Software)
Location: Oxford-based (on-site or hybrid)
Contract Duration: 6 months (potential to extend)
Key Responsibilities
- Define and implement test strategies aligned with GAMP5 and risk-based testing
- Plan and oversee testing across all phases: unit, integration, system, UAT, performance, and security
- Ensure validation activities comply with FDA 21 CFR Part 11, EU Annex 11, and GxP standards
- Create and maintain all validation documents: test plans, protocols (IQ, OQ, PQ), traceability, reports
- Lead test execution and defect management using tools like Jira/Xray
- Produce test summaries, quality metrics, and dashboards for internal stakeholders
- Continuously improve testing processes, tools, and regulatory practices
- Support software validation audits (internal and external)
Required Skills & Experience
- Degree in Computer Science, Software Engineering, or related technical field
- 3+ years in QA/testing in regulated industries (pharma, biotech, med device)
- Strong working knowledge of GAMP5 and validation requirements
- Broad experience in manual and functional testing, regression, UAT, and non-functional testing
- Proficient in test management and documentation tools (Jira, Xray, Confluence, MS Office)
- Excellent communicator with strong problem-solving and attention to detail
- Able to work independently within agile, collaborative teams
- ISTQB or equivalent certification
- Experience with automated testing frameworks
- Knowledge of Agile/Scrum, AWS/cloud, embedded systems, and IoT devices
- Familiarity with eQMS platforms (e.g., Ketryx, Cognidox)
Seniority level
-
Seniority level
Not Applicable
Employment type
-
Employment type
Contract
Job function
-
Job function
Consulting
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Freelance Test Manager (GAMP5) employer: Barrington James
Contact Detail:
Barrington James Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Freelance Test Manager (GAMP5)
✨Tip Number 1
Familiarise yourself with GAMP5 guidelines and the specific validation requirements for FDA 21 CFR Part 11 and EU Annex 11. This knowledge will not only help you in interviews but also demonstrate your commitment to compliance in regulated industries.
✨Tip Number 2
Network with professionals in the QA/testing field, especially those who have experience in pharma or biotech. Engaging with industry peers can provide valuable insights and potentially lead to referrals that increase your chances of landing the job.
✨Tip Number 3
Showcase your experience with tools like Jira and Xray by discussing specific projects where you successfully managed testing phases. Being able to articulate your hands-on experience with these tools will set you apart from other candidates.
✨Tip Number 4
Prepare to discuss how you've contributed to process improvements in previous roles. Highlighting your ability to enhance testing processes and regulatory practices will demonstrate your proactive approach and value to potential employers.
We think you need these skills to ace Freelance Test Manager (GAMP5)
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in QA/testing, especially in regulated industries. Emphasise your knowledge of GAMP5 and any specific tools like Jira or Xray that you've used.
Craft a Strong Cover Letter: In your cover letter, explain why you're a great fit for the Test Manager role. Mention your experience with FDA regulations and how you’ve successfully implemented test strategies in previous roles.
Showcase Your Skills: Clearly list your skills related to manual and functional testing, as well as any certifications like ISTQB. Highlight your problem-solving abilities and attention to detail, which are crucial for this position.
Follow Up: After submitting your application, consider sending a polite follow-up email to express your continued interest in the role. This can help keep you on the radar of the hiring team.
How to prepare for a job interview at Barrington James
✨Understand GAMP5 Thoroughly
Make sure you have a solid grasp of GAMP5 principles and how they apply to testing. Be prepared to discuss specific strategies you've implemented in past roles that align with GAMP5 compliance.
✨Showcase Your Documentation Skills
Since the role involves creating and maintaining validation documents, bring examples of your previous work. Highlight your experience with test plans, protocols, and reports to demonstrate your attention to detail.
✨Familiarise Yourself with Regulatory Standards
Brush up on FDA 21 CFR Part 11, EU Annex 11, and GxP standards. Be ready to explain how you've ensured compliance in your previous projects and how you would approach this in the new role.
✨Prepare for Technical Questions
Expect questions about your experience with tools like Jira and Xray, as well as your knowledge of automated testing frameworks. Be ready to discuss how you've used these tools to improve testing processes in your past roles.
