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- Tasks: Join a leading pharmaceutical company as a Validation Specialist, ensuring compliance and enhancing validation practices.
- Company: Hyper Recruitment Solutions is a top-tier recruitment agency specializing in the pharmaceutical sector.
- Benefits: Enjoy a dynamic work environment with opportunities for professional growth and development.
- Why this job: Make a real impact in the pharmaceutical industry while working with cutting-edge technology and processes.
- Qualifications: Experience in GMP environments and knowledge of EU/FDA regulations are essential for this role.
- Other info: This position requires an EU work permit and offers a chance to work in a cross-functional team.
The predicted salary is between 36000 - 60000 £ per year.
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Validation Specialist, Caerphilly County Borough
Client:
Hyper Recruitment Solutions
Location:
Caerphilly County Borough, United Kingdom
Job Category:
Other
EU work permit required:
Yes
Job Reference:
33c870bbcd52
Job Views:
6
Posted:
03.03.2025
Expiry Date:
17.04.2025
Job Description:
Role Overview
Are you an experienced Validation Specialist looking for a new exciting job opportunity?
We are currently looking for a Validation Specialist to join a leading pharmaceutical company based in the Caerphilly area.
As the Validation Specialist you will enhance validation practice and compliance; support improvement to validation system; streamline processes. Identify risk areas and required mitigation to meet regulatory inspections e.g. MHRA, FDA, Notified Body etc. through routine compliance activities and specific validation projects.
Key Duties and Responsibilities
Your duties as the Validation Specialist will be varied; however, the key duties and responsibilities are as follows:
- You will be responsible for ensuring that the Site Validation Master Plan is maintained accurately and Validation Plans are implemented for all relevant aspects of Equipment, Process, Cleaning, Computer Systems, Facilities/Utilities and Analytical Method validation.
- Additionally, you will also be assisting with all validation activities on equipment before handover/return to system owner and updating all relevant records and schedules. You will be responsible for arranging specialist services to maintain, calibrate and qualify specialist equipment.
- Technical input into all Validation Lifecycle activities as part of a cross-functional team. Provide guidance and support to other internal site departments ensuring compliance with applicable regulatory requirements (MHRA, EU, FDA, U.S., Notified Body and international), International Standards, and quality/validation regulations and guidance documents.
- You will also prepare and present validation reports and Key Performance Indicators for management review. Review and monitor trends; initiate continuous improvement opportunities, communicate any matters outside the norm to the Validation Manager/Site Director of Quality.
Role Requirements
To be successful in your application to this exciting opportunity as the Validation Specialist we are looking to identify the following on your profile and past history:
- Successful validation experience in a GMP environment (in the pharmaceutical, medical devices, consumer healthcare or semi-conductor industry) is essential for this position. Experience working in a sterile manufacturing facility would be highly desirable.
- Demonstrated expertise in cGMP’s, EU/FDA regulations, GAMP guidelines, assessment of risk and drafting of plans, protocols, reports and procedures.
- Previous team leadership experience (direct or indirect) desirable, operating in a matrix organization.
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Validation Specialist employer: TN United Kingdom
Contact Detail:
TN United Kingdom Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Validation Specialist
✨Tip Number 1
Make sure to familiarize yourself with the specific regulatory requirements such as MHRA and FDA guidelines. Understanding these regulations will not only help you in interviews but also demonstrate your commitment to compliance in the pharmaceutical industry.
✨Tip Number 2
Network with professionals in the validation field, especially those who have experience in GMP environments. Engaging with industry peers can provide insights into best practices and may even lead to referrals for job openings.
✨Tip Number 3
Highlight any experience you have with validation lifecycle activities and cross-functional teamwork. Being able to showcase your collaborative skills will be crucial, as this role involves working closely with various departments.
✨Tip Number 4
Prepare to discuss specific examples of how you've identified risk areas and implemented mitigation strategies in past roles. This practical knowledge will set you apart from other candidates and show that you can handle the responsibilities of the Validation Specialist position.
We think you need these skills to ace Validation Specialist
Some tips for your application 🫡
Understand the Role: Make sure to thoroughly read the job description for the Validation Specialist position. Highlight key responsibilities and requirements that match your experience, such as validation in a GMP environment and knowledge of regulatory standards.
Tailor Your CV: Customize your CV to emphasize relevant experience in validation processes, compliance with regulations like MHRA and FDA, and any leadership roles you've held. Use specific examples to demonstrate your expertise in the pharmaceutical industry.
Craft a Strong Cover Letter: Write a compelling cover letter that connects your background to the job requirements. Discuss your successful validation experiences, your understanding of cGMPs, and how you can contribute to the company's goals in maintaining compliance and improving validation practices.
Proofread Your Application: Before submitting your application, carefully proofread all documents for spelling and grammatical errors. Ensure that your information is clear and concise, reflecting your professionalism and attention to detail.
How to prepare for a job interview at TN United Kingdom
✨Showcase Your Validation Experience
Be prepared to discuss your previous validation experience in detail, especially in a GMP environment. Highlight specific projects you've worked on and the impact they had on compliance and efficiency.
✨Understand Regulatory Requirements
Familiarize yourself with the relevant regulatory bodies such as MHRA, FDA, and EU guidelines. Be ready to explain how you have ensured compliance in past roles and how you would approach it in this position.
✨Demonstrate Problem-Solving Skills
Prepare examples of how you've identified risk areas and implemented mitigation strategies in previous roles. This will show your proactive approach to validation challenges.
✨Prepare for Technical Questions
Expect technical questions related to validation lifecycle activities and GAMP guidelines. Brush up on your knowledge and be ready to discuss how you would apply these principles in the role.
