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- Tasks: Ensure electronic systems in Quality Control meet GMP standards and support drug product management.
- Company: Join a leading global pharmaceutical company known for its innovation and success.
- Benefits: Enjoy a permanent role with opportunities for professional growth and development.
- Why this job: Be part of a dynamic team that values quality and compliance in the pharmaceutical industry.
- Qualifications: Degree in a scientific field with experience in Electronic Quality Systems is essential.
- Other info: Applicants must have the right to work in the UK; reference job 128 633 when applying.
The predicted salary is between 36000 - 60000 £ per year.
CK Group are recruiting for a Quality Validation (CSV) Specialist, to join a well-established and successful global pharmaceutical company, based in Hatfield, Hertfordshire, on a permanent basis.
Role: This role is responsible for ensuring that electronic systems within the Quality Control Laboratory and the Quality Systems operate in accordance with the requirements of the departmental Standard Operating Procedures.
Key duties will include:
- Ensure the Electronic Quality Management System (QMS) and Quality Control Laboratory systems and software used to support the manufacture, packaging, testing, storage and distribution of marketed drug products comply with current GMP and company expectations.
- Provide input to the review and writing of any associated quality policies, systems and procedures as required and prepare and update SOPs and training materials for system administration activities, Qualification and Validation activities.
- Support the maintenance and administration of the Electronic QMS.
- Support the effective management of the administration of QC laboratory system applications providing independence of access for administrator activities.
- Ensure Qualification and Validation of equipment, processes, systems is/are performed in line with procedures, GMP and GAMP guidelines for process, equipment and electronic systems, as and when required.
- Ensure the maintenance of procedures supporting Qualification and Validation and review and approve Qualification and Validation documentation.
- Ensure user access to systems is maintained in line with procedures and support is provided to facilitate the set up and change management of system data and ensure continuous system availability and functionality.
- Support the Management of the relationships with external system providers for technical and helpdesk support and coordinate and lead system updates and upgrades with the system providers.
- Manage the provision of training on the requirements for CSV and IT qualification and validation.
- Support the change control process to ensure the requirements of qualification and validation are included.
Your Background:
- Educated to degree level or above in a scientific or related field with significant experience in a pharmaceutical industry role focused on Electronic Quality Systems.
- Proficient knowledge of electronic systems, CSV and GAMP requirements and the ability to understand and analyse user requirements to facilitate changes and system improvements.
- Good understanding of the requirements of data integrity and application to system management.
- Good understanding of Quality Control Systems and analytical software and electronic Quality Systems.
- Good understanding of GMP Guidelines and Regulations.
- Knowledge of the qualification and validation requirements for equipment and electronic systems.
- Excellent verbal and written communication skills.
It is essential that applicants hold entitlement to work in the UK. Please quote job reference 128 633 in all correspondence.
Quality Validation (CSV) Specialist employer: CK Group
Contact Detail:
CK Group Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Validation (CSV) Specialist
✨Tip Number 1
Familiarise yourself with the specific electronic quality management systems (QMS) used in the pharmaceutical industry. Understanding these systems will not only help you during interviews but also demonstrate your proactive approach to the role.
✨Tip Number 2
Network with professionals in the pharmaceutical sector, especially those involved in CSV and GAMP compliance. Engaging with industry experts can provide insights into the role and may even lead to referrals.
✨Tip Number 3
Stay updated on the latest GMP guidelines and regulations. Showing that you are knowledgeable about current standards will set you apart from other candidates and highlight your commitment to quality assurance.
✨Tip Number 4
Prepare to discuss real-world scenarios where you've successfully managed qualification and validation processes. Having concrete examples ready will showcase your experience and problem-solving skills effectively during the interview.
We think you need these skills to ace Quality Validation (CSV) Specialist
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities and requirements of the Quality Validation (CSV) Specialist position. Tailor your application to highlight how your skills and experiences align with the job description.
Craft a Strong CV: Your CV should clearly outline your educational background, relevant experience in the pharmaceutical industry, and specific knowledge of electronic quality systems. Use bullet points for clarity and ensure it is well-structured.
Write a Compelling Cover Letter: In your cover letter, express your enthusiasm for the role and the company. Highlight your understanding of GMP guidelines, CSV, and GAMP requirements, and provide examples of how you've successfully managed similar responsibilities in the past.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any spelling or grammatical errors. A polished application reflects your attention to detail, which is crucial for this role.
How to prepare for a job interview at CK Group
✨Know Your GMP and CSV Basics
Make sure you brush up on Good Manufacturing Practices (GMP) and Computer System Validation (CSV) principles. Being able to discuss these topics confidently will show that you understand the core requirements of the role.
✨Familiarise Yourself with GAMP Guidelines
Since the job involves working with GAMP guidelines, it’s crucial to have a solid understanding of them. Be prepared to explain how you've applied these guidelines in your previous roles or how you would approach them in this position.
✨Prepare Examples of Your Experience
Think of specific examples from your past work that demonstrate your experience with electronic quality systems and validation processes. Use the STAR method (Situation, Task, Action, Result) to structure your responses clearly.
✨Showcase Your Communication Skills
As the role requires excellent verbal and written communication skills, be ready to discuss how you’ve effectively communicated complex information in the past. Consider preparing a brief presentation or summary of a relevant project to showcase your ability.
