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- Tasks: Oversee GMP qualification activities and ensure compliance with regulatory standards.
- Company: Join Thermo Fisher Scientific, a global leader in science with a mission to make the world healthier.
- Benefits: Enjoy a dynamic work environment with comprehensive training and opportunities for growth.
- Why this job: Be part of a diverse team driving innovation and quality in pharmaceutical manufacturing.
- Qualifications: Bachelor's or Master's in Engineering or Life Sciences with 5+ years in Pharma manufacturing.
- Other info: Thermo Fisher values diversity and is committed to equal opportunity for all applicants.
The predicted salary is between 43200 - 72000 £ per year.
Work Schedule: Standard (Mon-Fri)
Environmental Conditions: Office
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Our global team of more than 100,000 colleagues delivers an outstanding combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands.
The state-of-the-art multi-purpose manufacturing facility is crafted for large-scale production of biologics and has high expansion potential. Our site in Lengnau offers highly flexible biomanufacturing technologies, from development to large-scale production including stainless steel and single-use equipment to meet our customer needs.
We are seeking a highly qualified Senior Quality Assurance Qualification Specialist to join our diverse team in Lengnau. As a global leader in scientific research and innovation, we are dedicated to enabling our customers to make the world healthier, cleaner, and safer. We are looking for a daring individual with confirmed experience in Pharma manufacturing site and a strong background in Engineering or Life Sciences.
Key Responsibilities:
- Work closely with cross-functional teams to oversee GMP aspects of qualification activities, ensuring the delivery of outstanding facilities, utilities, and equipment.
- Ensure compliance with cGMP regulatory expectations during qualification activities.
- Review and approve qualification activities in accordance with GMP standards.
- Assess and lead issues related to qualification, working closely with Manufacturing, QC, Engineering, and other relevant departments.
- Continuously improve quality standards for assigned quality systems and manufacturing areas.
- Review and approve quality systems-related documentation, ensuring compliant manufacturing of pharmaceutical products.
- Support internal and external inspections and drive the closure of identified gaps.
- Further active knowledge management and drive continuous improvement processes within the department.
Your Qualifications:
- Bachelor's or Master's degree in Engineering or Life Sciences (Biology, Chemistry, etc.), or equivalent.
- Minimum 5 years experience in Pharma manufacturing site.
- Proficiency in working with multicultural and cross-disciplinary project teams.
- Excellent organization, planning, problem solving and critical thinking skills.
- Excellent writing, communication, and presentation skills.
- Language: Proficiency in English, German knowledge preferable.
We offer a multifaceted job in a dynamic and international environment. A culture in which you live integrity, intensity, involvement, and innovation. A well-founded induction and task-specific training are a matter of course for us. You yourself resolve your future in our company – make your contribution to joint success!
As an employer, Thermo Fisher Scientific is committed to equal opportunity and cultural minority support and does not discriminate based on ethnic origin, colour, religion, gender, sexual orientation, gender identity, national origin, disability, or legally protected status.
Interested? Then apply online with the usual documents (up to a maximum of 2 MB).
Senior Scientist QM Qualification employer: Thermo Fisher Scientific Inc.
Contact Detail:
Thermo Fisher Scientific Inc. Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Scientist QM Qualification
✨Tip Number 1
Familiarise yourself with the latest cGMP regulations and guidelines. Understanding these standards will not only help you in interviews but also demonstrate your commitment to quality assurance in pharmaceutical manufacturing.
✨Tip Number 2
Network with professionals in the pharmaceutical industry, especially those who work in quality assurance roles. Attend relevant conferences or webinars to connect with potential colleagues and learn about the latest trends and challenges in the field.
✨Tip Number 3
Prepare to discuss specific examples from your past experience that highlight your problem-solving skills and ability to work in cross-functional teams. Be ready to explain how you've successfully navigated compliance issues or improved quality systems in previous roles.
✨Tip Number 4
Research Thermo Fisher Scientific's mission and values thoroughly. Tailor your discussions to reflect how your personal values align with their commitment to making the world healthier, cleaner, and safer, which can set you apart from other candidates.
We think you need these skills to ace Senior Scientist QM Qualification
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities and qualifications required for the Senior Scientist QM Qualification position. Tailor your application to highlight relevant experience in Pharma manufacturing and your background in Engineering or Life Sciences.
Craft a Strong CV: Your CV should clearly outline your educational background, work experience, and specific skills that align with the job description. Emphasise your experience in GMP compliance and any cross-functional team collaborations you've been involved in.
Write a Compelling Cover Letter: In your cover letter, express your passion for the role and the company’s mission. Highlight your problem-solving skills and how your previous experiences have prepared you for this position. Make sure to mention your proficiency in English and any knowledge of German.
Proofread Your Application: Before submitting, thoroughly proofread your CV and cover letter for any grammatical errors or typos. A polished application reflects your attention to detail, which is crucial for a role in quality assurance.
How to prepare for a job interview at Thermo Fisher Scientific Inc.
✨Understand GMP Regulations
Familiarise yourself with Good Manufacturing Practice (GMP) regulations, as this role heavily involves ensuring compliance. Be prepared to discuss how you have applied these standards in your previous roles.
✨Showcase Cross-Functional Collaboration
Highlight your experience working with cross-functional teams. Provide examples of how you've successfully collaborated with departments like Manufacturing, QC, and Engineering to achieve common goals.
✨Demonstrate Problem-Solving Skills
Prepare to discuss specific challenges you've faced in qualification activities and how you resolved them. This will showcase your critical thinking and problem-solving abilities, which are essential for this position.
✨Communicate Effectively
Since excellent communication skills are crucial, practice articulating your thoughts clearly and concisely. Be ready to present your ideas and experiences confidently during the interview.
