At a Glance
- Tasks: Lead eQMS implementation and ensure systems are audit-ready.
- Company: Join a dynamic team focused on global drug development.
- Benefits: Enjoy mentorship, a culture of innovation, and collaboration opportunities.
- Why this job: Make a real impact in pharmaceutical advancements while growing your skills.
- Qualifications: Degree in Life Sciences or related field; experience with QMS platforms required.
- Other info: Work with cutting-edge technologies and contribute to meaningful scientific challenges.
The predicted salary is between 36000 - 60000 £ per year.
Are you an QA Systems Specialist seeking their next exciting opportunity? We’re helping our client seek an experienced QA Systems Specialist to support the implementation, validation, and maintenance of electronic Quality Management Systems and pharmaceutical computerised systems.
Responsibilities
- Lead and support eQMS implementation, migration, and validation activities
- Maintain and manage system lifecycle documentation (URS, IQ/OQ/PQ, SOPs, etc.)
- Provide training and ongoing support to system users and stakeholders
- Ensure systems remain audit-ready and compliant with GxP, GLP, and CSV requirements
- Act as SME for validated systems and support continuous improvement
- Manage archiving processes and act as GLP archivist
- Communicate project progress and risks
Requirements
- Degree in Life Sciences, Engineering, Computer Science, or related field preferred
- Experience with MasterControl, ETQ, or similar QMS platforms
- Strong knowledge of CSV and pharmaceutical regulatory standards
- Experience with Empower CDS validation and data integrity
- Skilled in validation documentation and system configuration
- Excellent communication and project coordination skills
Benefits
- Contribute to impactful, global drug development initiatives
- Benefit from mentorship and guidance from experienced industry leaders
- Thrive in a culture rooted in integrity, innovation, and lifelong learning
- Collaborate across functions to tackle real-world scientific challenges
- Work with advanced technologies and proprietary research platforms
QA Systems Specialist employer: LinkedIn
Contact Detail:
LinkedIn Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land QA Systems Specialist
✨Tip Number 1
Familiarise yourself with the specific eQMS platforms mentioned in the job description, like MasterControl and ETQ. Having hands-on experience or even a basic understanding of these systems can set you apart from other candidates.
✨Tip Number 2
Brush up on your knowledge of GxP, GLP, and CSV requirements. Being able to discuss these regulations confidently during an interview will demonstrate your expertise and commitment to compliance in the pharmaceutical industry.
✨Tip Number 3
Prepare to showcase your project coordination skills by thinking of examples where you've successfully managed projects or led teams. Highlighting your ability to communicate effectively and manage risks will resonate well with the hiring team.
✨Tip Number 4
Network with professionals in the QA and pharmaceutical fields. Engaging with industry groups or attending relevant webinars can provide insights and connections that may help you learn more about the role and increase your chances of landing the job.
We think you need these skills to ace QA Systems Specialist
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in Quality Management Systems and any specific platforms like MasterControl or ETQ. Emphasise your knowledge of CSV and regulatory standards, as these are crucial for the role.
Craft a Compelling Cover Letter: In your cover letter, express your enthusiasm for the QA Systems Specialist position. Mention how your background in Life Sciences or Engineering aligns with the job requirements and how you can contribute to the company's goals.
Showcase Your Skills: When detailing your experience, focus on your skills in validation documentation, system configuration, and project coordination. Use specific examples to demonstrate your expertise and how you've successfully managed similar projects in the past.
Proofread Your Application: Before submitting, carefully proofread your application materials. Check for any spelling or grammatical errors, and ensure that all information is clear and concise. A polished application reflects your attention to detail, which is vital for this role.
How to prepare for a job interview at LinkedIn
✨Know Your Systems
Familiarise yourself with electronic Quality Management Systems, especially MasterControl and ETQ. Be prepared to discuss your experience with these platforms and how you've contributed to their implementation or validation in previous roles.
✨Understand Regulatory Standards
Brush up on your knowledge of GxP, GLP, and CSV requirements. Demonstrating a solid understanding of these standards will show that you are well-prepared to ensure compliance in the role.
✨Showcase Your Communication Skills
As a QA Systems Specialist, you'll need to communicate effectively with various stakeholders. Prepare examples of how you've successfully communicated project progress or risks in past projects to highlight your coordination skills.
✨Prepare for Scenario Questions
Expect scenario-based questions that assess your problem-solving abilities. Think about challenges you've faced in system validation or user training, and be ready to explain how you overcame them.