Technical Writer - 251313
仕事内容
We are seeking a Technical Writer with experience in sterile injectable manufacturing to support documentation and compliance in a regulated pharmaceutical environment.
This role combines desk-based documentation with hands-on floor support, approximately 50% on each.
Collaborate with manufacturing, quality, and validation teams to develop protocols, risk assessments, and regulatory documentation.
Author and maintain deviations, initial and final protocols, risk assessments, and 21 CFR Part 211 regulatory documentation; align with USP<1790> and USP <797>standards.
Support deviation investigations and ensure documentation meets regulatory and internal quality requirements.
Demonstrate strong cross-functional collaboration and clear, concise technical communication.
This role combines desk-based documentation with hands-on floor support, approximately 50% on each.
Collaborate with manufacturing, quality, and validation teams to develop protocols, risk assessments, and regulatory documentation.
Author and maintain deviations, initial and final protocols, risk assessments, and 21 CFR Part 211 regulatory documentation; align with USP<1790> and USP <797>standards.
Support deviation investigations and ensure documentation meets regulatory and internal quality requirements.
Demonstrate strong cross-functional collaboration and clear, concise technical communication.
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