Job description
We are seeking a detail-oriented Technical Writer to support deviation writing, data collection, and documentation processes within a biopharmaceutical environment. This role plays a critical part in ensuring accurate, compliant, and timely documentation to support quality systems and regulatory requirements.
Key Responsibilities
- Author, review, and edit deviation reports, ensuring clarity, accuracy, and compliance with internal procedures and regulatory standards
- Collaborate cross-functionally with Quality, Manufacturing, and Engineering teams to gather required data for investigations
- Support root cause analysis documentation and ensure proper alignment with collected data
- Organize and compile data from multiple sources to support deviation records and trending activities
- Ensure consistency and quality of technical documentation across systems
- Assist with CAPA (Corrective and Preventive Action) documentation as needed
- Maintain documentation in electronic quality management systems (eQMS)
- Track and manage documentation timelines to meet internal and regulatory deadlines
Required Qualifications
- Bachelor’s degree in Life Sciences, Engineering, Technical Writing, or related field
- 5+ years of experience in technical writing within biopharma, pharmaceutical, or regulated industries
- Experience supporting deviation investigations and quality documentation
- Strong understanding of GMP (Good Manufacturing Practices) environments
- Excellent written and verbal communication skills
- Ability to translate complex technical data into clear, concise documentation
- Strong attention to detail and organizational skills
Preferred Qualifications
- Familiarity with regulatory expectations (FDA, EMA)
- Experience supporting audits or inspections
- Knowledge of data trending and reporting tools
Key Competencies
- Analytical thinking and problem-solving
- Cross-functional collaboration
- Time management and ability to meet deadlines
- High level of accuracy and compliance focus
Why Join Us
- Opportunity to work in a fast-paced, highly regulated biopharma environment
- Contribute directly to product quality and patient safety
- Collaborative and innovative team culture…
Requirements
