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- 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.
Location: South East
Job Type: Permanent
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: Blackfield Associates
Contact Detail:
Blackfield Associates 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 during discussions.
✨Tip Number 2
Brush up on your knowledge of GxP, GLP, and CSV requirements. Being able to speak confidently about these regulations will demonstrate your expertise and commitment to compliance, which is crucial for this role.
✨Tip Number 3
Prepare to discuss your experience with validation documentation and system configuration. Be ready to share specific examples of how you've contributed to similar projects in the past, as this will highlight your practical skills.
✨Tip Number 4
Network with professionals in the pharmaceutical industry, especially those who work with quality management systems. Engaging with others in the field can provide valuable insights and potentially lead to referrals for the position.
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 provide examples of your experience with eQMS implementation and validation.
Highlight Relevant Skills: Clearly outline your skills in validation documentation, project coordination, and communication. These are key attributes for the role, so make sure they stand out in both your CV and cover letter.
Proofread Your Application: Before submitting, carefully proofread your application materials. Check for any spelling or grammatical errors, and ensure that all information is accurate and well-presented. A polished application reflects your attention to detail.
How to prepare for a job interview at Blackfield Associates
✨Know Your QMS Platforms
Familiarise yourself with MasterControl, ETQ, or any similar QMS platforms. Be prepared to discuss your experience with these systems and how you've used them in past roles.
✨Understand Regulatory Standards
Brush up on your knowledge of CSV and pharmaceutical regulatory standards. Being able to articulate how you ensure compliance will show your expertise and readiness for the role.
✨Prepare for Scenario Questions
Expect questions that ask you to describe how you would handle specific situations related to eQMS implementation or validation. Think of examples from your past experiences that demonstrate your problem-solving skills.
✨Showcase Your Communication Skills
Since excellent communication is key for this role, practice articulating your thoughts clearly. Be ready to explain complex concepts in a way that’s easy to understand, as you’ll need to train users and communicate project progress.
