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- Tasks: Oversee QA validation activities ensuring compliance with GMP requirements.
- Company: Join a global leader in CDMO services, shaping the future of pharmaceuticals.
- Benefits: Enjoy a permanent role with full-time hours and opportunities for professional growth.
- Why this job: Be part of a dynamic team driving quality and innovation in the pharmaceutical industry.
- Qualifications: Technical experience in GMP environments and strong project management skills required.
- Other info: Embrace a culture of diversity and inclusion while influencing key stakeholders.
The predicted salary is between 36000 - 60000 £ per year.
Job Title: Quality Assurance (QA) Validation Specialist
Location: Yorkshire/Humber
Contract: Permanent, Full Time
Work Hours: 37.5
Randstad Sourceright, a leading provider of RPO & MSP Recruitment Services are currently recruiting for a Quality Assurance (QA) Validation Specialist on behalf of a global CDMO organization.
Role Purpose:
In this role you will have the QA oversight and control of site Validation activities to ensure compliance and cover a broad spectrum of validation disciplines, including but not limited to:
- Process Validation / CPV
- Facility and Equipment Validation/Qualification
- Cleaning Validation
- Storage Area Validation
- Analytical Method Validation
- You will ensure validation processes, procedures and execution are in compliance with GMP requirements.
Key Accountabilities:
- Own the Site Validation Master Plan
- Implementation and oversight of robust Validation Lifecycle based procedures and business processes with key stakeholders
- Review and approval of Validation protocols and reports
- QA lead SME for Validation related topics within Audits and Inspections
- QA SME for GMP engineering qualification projects, ensuring compliance to site and corporate procedures
- Design and conduct training and education
- Oversight of periodic verifications and reports (Equipment, process, temperature mapping etc.)
- QA Support and input to applicable deviations and change controls
- Collaborate with key stakeholders to deliver robust business processes and improvements
- Monitoring and oversight of critical clean utilities from quality perspective (e.g. Purified Water, Nitrogen, Cleanrooms etc.)
- Work closely with site eCompliance Lead supporting Computer System Validation
- Ensure data generated/supporting validation is in compliance with ALCOA+ principles throughout its lifecycle
Key Requirements:
- Technical experience within GMP / Pharmaceutical environment, including managing projects and validation activities.
- Broad knowledge of Validation concepts and Lifecycle verification.
- Focus on high quality; good at planning, organizing and communication.
- Empowerment, motivating others and development direction.
- Understands how to effectively engage others within project/change processes.
- Champion and role model the values of diversity and inclusion through everyday interactions.
- Ensure clear and direct 2-way communication within their team and other organizations.
- Able to work cross-functionally, indirectly influencing key stakeholders.
- Proactive, take responsibility within their area of the business.
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QA Validation Specialist employer: Randstad Enterprise
Contact Detail:
Randstad Enterprise Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land QA Validation Specialist
✨Tip Number 1
Familiarise yourself with the latest GMP regulations and validation processes. This will not only help you understand the role better but also demonstrate your commitment to compliance during interviews.
✨Tip Number 2
Network with professionals in the QA and validation field, especially those who work in pharmaceutical environments. Attend industry events or join relevant online forums to gain insights and make connections that could lead to job opportunities.
✨Tip Number 3
Prepare to discuss specific examples of your experience with validation activities and how you've ensured compliance in previous roles. Being able to articulate your hands-on experience will set you apart from other candidates.
✨Tip Number 4
Showcase your ability to work cross-functionally by highlighting any past experiences where you collaborated with different teams. This is crucial for the role, as it involves engaging with various stakeholders to improve business processes.
We think you need these skills to ace QA Validation Specialist
Some tips for your application 🫡
Understand the Role: Before applying, make sure to thoroughly read the job description for the QA Validation Specialist position. Understand the key responsibilities and requirements, especially those related to GMP compliance and validation processes.
Tailor Your CV: Customise your CV to highlight relevant experience in quality assurance and validation within a GMP or pharmaceutical environment. Emphasise your project management skills and any specific validation activities you've managed.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for quality assurance and your understanding of the role. Mention specific experiences that align with the key accountabilities listed in the job description, such as your involvement in validation protocols or training.
Highlight Soft Skills: In your application, don't forget to mention your soft skills, such as communication, teamwork, and leadership. These are crucial for the role, especially when collaborating with stakeholders and leading training sessions.
How to prepare for a job interview at Randstad Enterprise
✨Understand the Validation Lifecycle
Make sure you have a solid grasp of the validation lifecycle and its importance in the QA process. Be prepared to discuss how you have implemented or overseen validation activities in previous roles, as this will demonstrate your expertise and relevance to the position.
✨Showcase Your GMP Knowledge
Since the role requires compliance with GMP requirements, brush up on your knowledge of Good Manufacturing Practices. Be ready to provide examples of how you've ensured compliance in past projects, as this will highlight your suitability for the role.
✨Prepare for Scenario-Based Questions
Expect scenario-based questions that assess your problem-solving skills and ability to handle validation challenges. Think of specific situations where you successfully navigated issues related to validation processes and be ready to share those experiences.
✨Emphasise Communication Skills
Effective communication is key in this role, especially when collaborating with stakeholders. Prepare to discuss how you've engaged with different teams and influenced project outcomes through clear communication, as this will showcase your ability to work cross-functionally.
