Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
When you join us at Thermo Fisher Scientific, you’ll be part of an inquisitive team that shares your passion for exploration and discovery. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and chances to create significant contributions to the world.
This role is responsible for supporting our department by documenting and managing deviations and changes in the manufacturing process. This role involves writing clear and comprehensive technical documents, ensuring compliance with GMP standards, and collaborating with cross-functional teams to support continuous improvement initiatives.
Position Responsibilities & Accountabilities
Technical Responsibilities
* Deviation Documentation: Document deviations, including root cause analysis, corrective actions, and preventive measures.
* Process Change Oversight: Draft and manage change control records, ensuring changes are accurately captured and approved per GMP standards.
* Technical Writing: Produce clear, concise technical documents, such as SOPs, work instructions, and reports.
* Compliance: Ensure documentation aligns with GMP standards and regulatory requirements.
* Collaboration: Partner with production, quality, and engineering teams to gather information and ensure accurate documentation.
* Continuous Improvement: Identify and implement improvements to enhance documentation and change control practices.
* Training Support: Train and guide staff on deviation and change control procedures.
* Audit Support: Support audits by providing documentation and resolving findings related to deviations and change management.
Quality
* Adheres to general cGMP rules, Quality policies, procedures and instruction as rolled out by the Quality function and endorsed by the site management.
EHSS
* Adheres to general safety rules, policies, procedures and instructions as rolled out by the EHSS functions and endorsed by the site management.
* Actively contributes to safety initiatives and issues as well as near miss reporting and follow-up.
Values & Behaviour
* Maintains commitment to Thermo Fisher Scientific values and adherence to ethics and legal compliance standards.
* Takes personal accountability for their presence, performance, and productivity for the achievements of defined objectives.
* Thinks and acts with a customer-centric mentality.
* Is intellectually curious and embraces Practical Process Improvement (PPI).
Position Qualifications
Education
* Bachelor’s degree in a scientific or technical field (e.g., Life Sciences, Engineering, Technical Writing).
Experience & Competences
* Minimum of 2-3 years of experience in technical writing, deviation management, or change control, preferably within the pharmaceutical or biotechnology industry.
* Demonstrated experience in documenting deviations and managing change control processes.
* Strong understanding of GMP standards and regulatory requirements.
* Excellent technical writing skills with attention to detail.
* Proficiency in PC applications, including MS Office.
* Strong communication and interpersonal skills.
* Certification in technical writing or quality management.
* Experience with electronic documentation management systems (e.g., Documentum, TrackWise).
Additional Requirements
* Ability to work independently, manage priorities, and take ownership of tasks.
* Strong attention to detail in documenting activities in compliance with GMP standards.
* Participation in quality improvement initiatives and deviation reporting.
* Analytical and concept-based thinking and acting.
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