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For Companies At a Glance
- Tasks: Ensure quality assurance in clinical trials and support manufacturing processes.
- Company: Join a leading firm in the Pharmaceuticals and Medical Products industry.
- Benefits: Enjoy competitive pay, career growth opportunities, and a collaborative work environment.
- Why this job: Be part of impactful projects that improve healthcare and enhance patient safety.
- Qualifications: Experience in quality assurance and knowledge of FDA regulations required.
- Other info: Located in Exton, Pennsylvania, with a focus on innovation and excellence.
The predicted salary is between 48000 - 84000 £ per year.
Description
We\’re looking for a Senior Quality Specialist , working in the Pharmaceuticals and Medical Products industry in 210 Welsh Pool Road, Exton, Pennsylvania, 19341, United States .
Responsibilities:
- Provides quality assurance support of validation, manufacturing, and testing of clinical trials materials and serves as a quality assurance resource for the Pilot Plant staff.
- Provides quality support within the Pilot Plant in the execution of key quality systems, including equipment, system, and utility validation, SIP, Autoclave, and ongoing process improvement efforts.
- Provides quality support to processes such as batch release, deviation and CAPA management, facility management/maintenance processes, validation, and change management.
- Provides review of technical, validation, and other protocols and reports, with emphasis on adherence to quality systems, and with FDA, EMEA, ICH, and JP regulations/guidance.
- Maintains Quality systems while ensuring seamless and efficient efforts are applied to ongoing validation, maintenance, automation, and change management processes while ensuring compliance with established policies and procedures.
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Contact Detail:
PSG Global Solutions Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Quality Specialist
✨Tip Number 1
Familiarise yourself with the latest FDA, EMEA, ICH, and JP regulations. Understanding these guidelines will not only help you in interviews but also demonstrate your commitment to quality assurance in the pharmaceutical industry.
✨Tip Number 2
Network with professionals in the pharmaceuticals and medical products sector. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends and challenges in quality assurance.
✨Tip Number 3
Prepare to discuss specific examples of how you've contributed to quality systems in previous roles. Highlight your experience with validation, batch release, and CAPA management to showcase your expertise.
✨Tip Number 4
Research StudySmarter's values and mission. Tailoring your conversation to align with our goals can make a strong impression during interviews and show that you're genuinely interested in being part of our team.
We think you need these skills to ace Senior Quality Specialist
Some tips for your application 🫡
Understand the Role: Read the job description thoroughly to understand the responsibilities and requirements of the Senior Quality Specialist position. Tailor your application to highlight relevant experience in quality assurance, validation, and compliance with regulations.
Highlight Relevant Experience: In your CV and cover letter, emphasise your experience in the pharmaceuticals and medical products industry. Include specific examples of your work with quality systems, validation processes, and adherence to regulatory standards like FDA and ICH.
Craft a Strong Cover Letter: Write a compelling cover letter that connects your skills and experiences to the key responsibilities outlined in the job description. Show enthusiasm for the role and the company, and explain why you are a great fit for their team.
Proofread Your Application: Before submitting your application, carefully proofread all documents for spelling and grammatical errors. A polished application reflects your attention to detail, which is crucial for a quality specialist role.
How to prepare for a job interview at PSG Global Solutions
✨Understand Quality Systems
Familiarise yourself with key quality systems relevant to the role, such as validation processes and compliance with FDA and EMEA regulations. Be prepared to discuss how you have applied these systems in your previous roles.
✨Showcase Your Experience
Highlight your experience in quality assurance, particularly in the pharmaceuticals and medical products industry. Use specific examples of how you've contributed to batch release, deviation management, or CAPA processes.
✨Prepare for Technical Questions
Expect technical questions related to validation, equipment, and process improvement. Brush up on your knowledge of SIP, Autoclave processes, and any relevant protocols to demonstrate your expertise.
✨Emphasise Team Collaboration
Quality specialists often work closely with various teams. Be ready to discuss how you’ve collaborated with manufacturing and testing teams to ensure quality standards are met, showcasing your ability to work effectively in a team environment.
