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- Tasks: Ensure quality assurance in clinical trials and support manufacturing processes.
- Company: Join a leading company in the Pharmaceuticals and Medical Products industry.
- Benefits: Enjoy a dynamic work environment with opportunities for professional growth.
- Why this job: Be part of impactful projects that improve healthcare and patient outcomes.
- Qualifications: Experience in quality assurance and knowledge of FDA regulations required.
- Other info: Located in Exton, Pennsylvania, with a focus on innovation and compliance.
The predicted salary is between 43200 - 72000 £ 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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Senior Quality Specialist employer: PSG Global Solutions
Contact Detail:
PSG Global Solutions Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Quality Specialist
✨Tip Number 1
Familiarize yourself with the specific quality assurance processes and regulations relevant to the Pharmaceuticals and Medical Products industry. Understanding FDA, EMEA, ICH, and JP guidelines will give you a significant edge during interviews.
✨Tip Number 2
Network with professionals in the field of quality assurance within the pharmaceutical sector. Attend industry conferences or webinars to connect with potential colleagues and learn about current trends and challenges.
✨Tip Number 3
Prepare to discuss your experience with key quality systems and validation processes in detail. Be ready to provide examples of how you've contributed to ongoing process improvements in previous roles.
✨Tip Number 4
Research StudySmarter's values and mission to align your responses during the interview. Showing that you understand our company culture can help you stand out as a candidate who fits well with our team.
We think you need these skills to ace Senior Quality Specialist
Some tips for your application 🫡
Understand the Role: Make sure to thoroughly read the job description for the Senior Quality Specialist position. Understand the key responsibilities and required qualifications, especially in relation to quality assurance in pharmaceuticals and medical products.
Highlight Relevant Experience: In your application, emphasize your experience with quality assurance processes, validation, and compliance with FDA and other regulatory standards. Use specific examples from your past roles that demonstrate your expertise in these areas.
Tailor Your CV: Customize your CV to reflect the skills and experiences that align with the job requirements. Focus on your achievements in quality systems, batch release processes, and any relevant certifications you may hold.
Craft a Strong Cover Letter: Write a compelling cover letter that not only summarizes your qualifications but also expresses your passion for quality assurance in the pharmaceutical industry. Mention why you are interested in this specific role and how you can contribute to the company's success.
How to prepare for a job interview at PSG Global Solutions
✨Understand Quality Assurance Fundamentals
Make sure you have a solid grasp of quality assurance principles, especially in the context of pharmaceuticals and medical products. Be prepared to discuss how you have applied these principles in past roles, particularly in validation and compliance with FDA and ICH regulations.
✨Showcase Your Experience with Key Quality Systems
Highlight your experience with key quality systems such as equipment validation, batch release processes, and CAPA management. Be ready to provide specific examples of how you've contributed to ongoing process improvements in these areas.
✨Demonstrate Problem-Solving Skills
Prepare to discuss situations where you've encountered challenges in quality assurance and how you resolved them. This could include managing deviations or implementing change management processes. Employers value candidates who can think critically and act decisively.
✨Familiarize Yourself with Regulatory Standards
Brush up on relevant regulations and guidance from the FDA, EMEA, and JP. Being able to articulate how these regulations impact quality assurance practices will show that you are knowledgeable and prepared for the role.
