This role involves documenting deviations, managing change control, and producing technical documents while ensuring compliance with GMP standards. Collaboration with various teams, along with a strong commitment to safety and quality, is essential.
Anforderungen
- •Bachelor's degree in scientific or technical field
- •Minimum 2-3 years in technical writing
- •Experience in documenting deviations
- •Strong understanding of GMP standards
- •Excellent technical writing skills
- •Proficiency in MS Office applications
- •Strong communication and interpersonal skills
- •Certification in technical writing or quality management
- •Experience with electronic documentation systems
- •Ability to work independently and manage priorities
- •Strong attention to detail in documentation
- •Participation in quality improvement initiatives
- •Analytical and concept-based thinking
Deine Aufgaben
- •Document deviations with root cause analysis.
- •Draft and manage change control records.
- •Produce clear technical documents and reports.
- •Ensure documentation meets GMP and regulatory standards.
- •Collaborate with production, quality, and engineering teams.
- •Identify and implement improvements in documentation practices.
- •Train staff on deviation and change control procedures.
- •Support audits with relevant documentation and findings.
- •Adhere to cGMP rules and Quality policies.
- •Follow general safety rules and procedures.
- •Contribute to safety initiatives and near miss reporting.
- •Commit to corporate values and ethical standards.
- •Take accountability for performance and productivity.
- •Maintain a customer-centric mindset.
- •Embrace Practical Process Improvement (PPI).
Original Beschreibung
# Technical Documentation & Compliance
**Lengnau, Switzerland** | **Full time** | **Fully Onsite**
**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. 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.