Technical Writer
Core
Conducts independent investigations of process deviations and customer complaints to determine root causes and initiate corrective/preventative actions to ensure product quality and patient safety.
Role type
Quality Assurance Investigator (Pharmaceutical Manufacturing)
Builds
Corrective and preventative action plans for manufacturing deviations
Domain
Pharmaceutical manufacturing / Quality Management Systems
Deliverable
client delivery (investigation reports and CAPA)
Required skills
Root cause analysis, risk assessment, data analysis, compliance with GMP, trend analysis, technical writing, MS Office
Preferred skills
None stated
Technologies
MS Office (Word, Excel)
Responsibilities
Investigate process deviations and customer complaints, analyze manufacturing and laboratory data, communicate root causes to senior management, update compliance documentation, perform trend analysis
Seniority
Mid-level, independent contributor