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- Tasks: Manage Change Controls and ensure compliance in a fast-paced pharmaceutical environment.
- Company: Join Proclinical, a leading recruiter in life sciences, driving healthcare innovation.
- Benefits: Enjoy a collaborative culture with opportunities for professional growth and development.
- Why this job: Make a real impact on patient care while working with cutting-edge quality management systems.
- Qualifications: Degree in Life Sciences or equivalent experience; familiarity with GxP regulations is essential.
- Other info: Remote work options may be available; contact Josh Godden for application assistance.
The predicted salary is between 36000 - 60000 £ per year.
Job Description
Help bring science to life and join a leading pharmaceutical company to play a key role in delivering impactful research that drives healthcare innovation!
Proclinical is seeking a QA Specialist to support the operational implementation and continuous improvement of Quality Management Systems (QMS) within a pharmaceutical environment. This role focuses on managing Change Controls, Deviations, and CAPA processes from a quality assurance perspective. If you are passionate about contributing to a patient-centric organization and thrive in a fast-paced, collaborative setting, this opportunity could be for you.
Responsibilities:
- Manage Change Controls, including gathering impact assessments, leading risk assessments, and ensuring timely approvals and closures.
- Support internal stakeholders with risk assessments aligned with ICH Q9 principles to implement mitigation measures.
- Oversee the classification and documentation of changes, ensuring traceability and compliance.
- Assist in the initiation, assessment, investigation, and lifecycle management of Deviations, CAPAs, and Change Controls.
- Ensure accurate and compliant documentation of quality events within defined timelines using electronic QMS tools.
- Collaborate with cross-functional teams to facilitate timely closure of quality events.
- Lead or assist in root cause analysis using tools like 5 Whys or Fishbone diagrams.
- Support the creation, revision, and management of QA-controlled documents, including SOPs and Work Instructions.
- Track and ensure SOP training completion for compliance.
- Prepare KPIs and Quality Metrics related to Deviation, CAPA, and Change Control processes.
- Contribute to trend analysis and participate in Quality Review or Management Review meetings.
- Assist in configuring and maintaining the Veeva Vault platform and provide user support as needed.
Key Skills and Requirements:
- Degree in Life Sciences (e.g., Pharmacy, Chemistry, Biology) or equivalent professional experience.
- Experience in a GxP-regulated pharmaceutical environment (GDP or GMP).
- Familiarity with quality system processes such as Deviation, CAPA, and Change Control.
- Knowledge of EU GDP/GMP guidelines, MHRA expectations, and EudraLex Vol 4.
- Proficiency with electronic QMS tools (e.g., Veeva, Trackwise, MasterControl).
- Strong problem-solving skills and ability to adapt to high-speed change.
- Attention to detail, documentation accuracy, and a results-driven mindset.
- Effective communication and collaboration skills.
- Ability to work independently with minimal supervision.
If you are having difficulty in applying or if you have any questions, please contact Josh Godden at j.godden@proclinical.com.
Apply Now:
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.
By submitting this application, you confirm that you've read and understood our privacy policy, which informs you how we process and safeguard your data – https://www.proclinical.com/privacy-policy
QA Specialist, Change Controls & Deviations employer: Proclinical Staffing
Contact Detail:
Proclinical Staffing Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land QA Specialist, Change Controls & Deviations
✨Tip Number 1
Familiarise yourself with the specific quality management systems (QMS) used in the pharmaceutical industry, particularly Veeva Vault. Understanding how these tools function will give you an edge during interviews and demonstrate your readiness to hit the ground running.
✨Tip Number 2
Brush up on your knowledge of EU GDP/GMP guidelines and MHRA expectations. Being well-versed in these regulations will not only help you answer technical questions but also show your commitment to compliance and quality assurance.
✨Tip Number 3
Prepare examples from your past experiences where you've successfully managed change controls or deviations. Use the STAR method (Situation, Task, Action, Result) to structure your responses, as this will help you articulate your problem-solving skills effectively.
✨Tip Number 4
Network with professionals in the pharmaceutical industry, especially those working in quality assurance roles. Engaging with them can provide insights into the company culture and expectations, which can be invaluable during your application process.
We think you need these skills to ace QA Specialist, Change Controls & Deviations
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in quality assurance, particularly in managing Change Controls, Deviations, and CAPA processes. Use specific examples that demonstrate your familiarity with GxP regulations and electronic QMS tools.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for the pharmaceutical industry and your commitment to patient-centric practices. Mention how your skills align with the responsibilities outlined in the job description, such as risk assessments and documentation accuracy.
Highlight Relevant Skills: In your application, emphasise key skills such as problem-solving, attention to detail, and effective communication. Provide examples of how you've successfully collaborated with cross-functional teams in previous roles.
Proofread Your Application: Before submitting, thoroughly proofread your application materials to ensure there are no spelling or grammatical errors. A polished application reflects your attention to detail, which is crucial for a QA Specialist role.
How to prepare for a job interview at Proclinical Staffing
✨Know Your Quality Management Systems
Familiarise yourself with the key concepts of Quality Management Systems (QMS) and how they apply to Change Controls, Deviations, and CAPA processes. Be prepared to discuss your experience with these systems and any specific tools you've used, such as Veeva or Trackwise.
✨Demonstrate Problem-Solving Skills
Prepare examples that showcase your problem-solving abilities, especially in high-pressure situations. Use the STAR method (Situation, Task, Action, Result) to structure your responses, particularly when discussing root cause analysis techniques like 5 Whys or Fishbone diagrams.
✨Highlight Attention to Detail
Since this role requires meticulous documentation and compliance, be ready to provide examples of how you've ensured accuracy in your previous work. Discuss any experiences where your attention to detail made a significant impact on project outcomes.
✨Showcase Collaboration Skills
This position involves working with cross-functional teams, so be prepared to talk about your collaborative experiences. Highlight instances where you successfully facilitated communication between different departments to achieve timely closure of quality events.
