Quality Specialist III

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

This role reports into the Tilburg site of the Thermo Fisher Scientific Pharmaceutical Services Group. The site produces soft gelatin capsules.

How will you make an impact?

The Quality Specialist III is responsible for collaborating with a team of QA personnel supporting GMP facilities and utilities used in drug product manufacturing, at Thermo Fisher in Tilburg, The Netherlands. The focus of the position is to lead investigations, respond to and drive audit commitments, drive CAPAs Deviations, Change Control, implement procedural improvements and drive compliance in the site.

Essential Responsibilities:

• Lead and chip in cross-functional meetings to conduct root-cause analysis and determine corrective and preventative actions
• Generate and close CAPAs, Changes, and Deviations including: re-training, SOP revisions, and implementation of new processes within the site
• Identify recurring events and trends within site deviations and propose continuous improvement ideas based on findings
• Assist in the creation, implementation and maintenance of training curriculum, as well as the launch of learning-based training elements for personnel
• Support the site in maintenance of audit readiness
• Perform gap analysis to new and existing regulations and standards
• Partner cross-functionally to implement process improvements; participates and/or may lead cross functional projects.
• Drive continuous improvement and operational excellence culture thru self-detecting and self-correcting processes and systems and instilling strong ownership and accountability.
• Recognize, understand and respond to situations requiring further evaluation and report these events to area management

Knowledge, Skill, and Requirements:

• Bachelor's degree and 2 years of related work experience in a pharmaceutical work environment.
• Proven track record to collaborate across the business.
• Strong analytical and problem-solving skills; great attention to detail and excellent decision-making process.
• Expertise in handling small and medium technical and/or capital projects.
• Proven ability to present ideas persuasively and negotiate effectively.
• Excellent written and oral communication skills both internal and external.

Physical Demands:

• Ability to function in a dynamic environment and balance multiple priorities simultaneously.
• Ability to learn new software and tools quickly.
• Ability to make decisions and work with minimal to moderate supervision.
• While performing the duties of this job, the employee is required to write, read/review written documentation for extended periods of time.