Technical Writer
Technical Writer
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Salary Not Disclosed
1 Vacancy
Job Description
Technical Writer Deviations & Change Control
Our client a pharmaceutical manufacturing company is seeking a detailoriented Technical Writer with expertise in deviations and change control documentation. This onsite role plays a critical part in ensuring regulatory compliance and supporting quality operations through precise timely and accurate technical documentation.
Key Responsibilities
- Write edit and review highquality technical documents including deviations change controls CAPAs and other GMPrelated records.
- Collaborate with crossfunctional teams (QA Manufacturing Engineering etc. to gather accurate and complete information.
- Ensure all documentation complies with FDA EU and internal GMP guidelines.
- Translate complex technical information into clear concise and wellstructured documents.
- Assist in audit readiness by maintaining organized traceable documentation.
- Support investigations and root cause analyses by drafting clear summaries and conclusions.
Qualifications
- Bachelors degree in Life Sciences Engineering or a related field.
- 5 years of experience in technical writing within the pharmaceutical or biotech industry.
- Strong knowledge of GMP deviation management and change control processes.
- Excellent writing editing and communication skills.
- Proficient with Microsoft Office Suite; experience with TrackWise or other QMS platforms a plus.
- Detailoriented organized and able to manage multiple priorities in a fastpaced environment.
Applicants must be authorized to work in the United States. Sponsorship is not available for this position.
Employment Type
Full Time
