At a Glance
- Tasks: Validate equipment and systems to ensure compliance and safety in a dynamic environment.
- Company: Join Thermo Fisher Scientific, a leader in making the world healthier and safer.
- Benefits: Competitive salary, career growth opportunities, and a supportive team culture.
- Other info: Flexible work style and commitment to continuous improvement are essential.
- Why this job: Make a real impact on global health and safety while developing your skills.
- Qualifications: Experience in pharmaceutical/GMP environments and strong communication skills.
The predicted salary is between 40500 - 49500 £ per year.
Work Schedule Standard (Mon-Fri)
Environmental Conditions:
- Adherence to all Good Manufacturing Practices (GMP)
- Safety Standards
- Cold Room/Freezers -22 degrees F/-6 degrees C
- Office
- Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
Reports To: QA Validation Manager
Group/Division: Pharma Services Group/Clinical Trials Division
Position Location: Horsham
Number of Direct Reports: 0
Position Summary:
As a QA Validation Specialist, you will be responsible for interacting with various departments to provide validation support to validate equipment, equipment systems and computer systems along with the critical utilities and facilities required for operations at the Horsham & Crawley Sites. You will work as part of the QA Validation team to establish engineering specifications and requirements for implementation and procurement of commercial equipment. You will be responsible for ensuring site compliance and all vital activities are performed on time to keep all site validated systems in a validated state.
Key Responsibilities:
- To lead, coordinate, perform, author, and support validation/qualifications, reviews and change control activities including equipment, facilities, systems, cleaning, distribution and CSV
- To agree scope of validation/qualification activities in line with company and regulatory requirements
- Work closely with engineering and operations to write and perform qualification and validation documents including URS, SIA, VP, DQ, Factory Acceptance Testing (FAT, requiring some travel), Site Acceptance Testing (SAT), IQ, OQ, PQ, CSV, PV and VSR
- Provide support on validation-related issues and site systems/equipment, assisting in audits and inspections
- To champion validation activities and training material and carry out training in validation/qualification
- Ensure the schedule is maintained, reports are written on time, and related documents are current according to the site master plan
- Author SOPs related to validation activities and where required for projects
- Represent QA validation in cross-functional meetings/projects as needed
- Conduct root cause analysis and deviation resolution for validation exceptions
- Support related activities within validation and compliance as required by the Validation Manager
- Actively participate in departmental improvement programmes
- Conduct all activities in a safe and efficient manner
- Perform other relevant additional duties as requested by the QA Validation Manager in line with business needs.
Experience, Knowledge & Skills:
- Relevant Pharmaceutical/GMP proven experience
- Previous experience in a validation/CSV role
- Knowledge of GMP legislation
- Experience dealing with regulatory authorities
- Excellent presentational and motivational skills
- Ability to establish effective working relationships and communicate effectively
- Ability to prioritise own workload to deliver personal and team objectives within set timeframes
How will you get here?
Demonstrate behaviours in line with the Thermo Fisher Core Competencies and 4i Values. Takes ownership, accepts responsibility for your actions and always makes sound decisions with solid communication skills. Demonstrate an adaptive and flexible work style shown to be effective working across varied types of clients, product types and front-line team members. Ensure compliance with cGMP and training requirements are met in line with business need.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
QA Validation Specialist in Horsham employer: Thermofisher Scientific
At Thermo Fisher Scientific, we pride ourselves on being an exceptional employer, offering a collaborative work culture that fosters innovation and personal growth. Located in Horsham, our team enjoys a supportive environment with access to cutting-edge resources, enabling employees to make a meaningful impact on global health and safety. We are committed to your professional development, providing opportunities for training and advancement while ensuring compliance with the highest standards of Good Manufacturing Practices.
StudySmarter Expert Advice🤫
We think this is how you could land QA Validation Specialist in Horsham
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We think you need these skills to ace QA Validation Specialist in Horsham
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Thermofisher Scientific!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Thermofisher Scientific that you're not just a fit for the job but also a safety-conscious candidate!
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How to prepare for a job interview at Thermofisher Scientific
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Thermofisher Scientific that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
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If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Thermofisher Scientific’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
