Senior Scientist QM Qualification

Thermo Fisher Scientific Inc.; Swindon; On-site; GBP 45,000 - 65,000; Full time

Job summary

A leading company in science is seeking a Senior Quality Assurance Qualification Specialist for its manufacturing facility in Swindon. The ideal candidate will have a strong background in Pharma manufacturing, with a focus on engineering or life sciences. This role involves close collaboration with cross-functional teams to ensure compliance with quality standards and regulatory expectations.

Qualifications

• Minimum 5 years experience in Pharma manufacturing.
• Proficiency in working with multicultural and cross-disciplinary teams.
• Fluency in English, German knowledge preferable.

Responsibilities

• Oversee GMP aspects of qualification activities.
• Ensure compliance with cGMP regulatory expectations.
• Review and approve qualification activities according to GMP standards.

Skills

Problem solving

Critical thinking

Communication

Presentation

Education

Bachelor's or Master's degree in Engineering or Life Sciences

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

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, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.

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 Specialistto 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.
• min 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 http://jobs.thermofisher.com with the usual documents (up to a maximum of 2 MB)