Shrive Technologies
Technical Writer/Validation Specialist
Shrive Technologies, West Point, Pennsylvania, us, 19486
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Technical Writer/Validation Specialist
role at
Shrive Technologies
Responsibilities
Develop and maintain SOPs, user manuals, validation protocols, and regulatory submission documents.
Translate complex scientific and technical concepts into clear, concise documentation.
Collaborate with SMEs to gather and verify technical information.
Ensure documentation complies with industry standards (GxP, ISO, ICH).
Author and execute validation protocols (IQ/OQ/PQ) for equipment, software, and processes.
Perform Computer System Validation (CSV) in accordance with 21 CFR Part 11 and GAMP 5.
Conduct risk assessments and support change control processes.
Review and approve validation documentation and reports.
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Technical Writer/Validation Specialist
role at
Shrive Technologies
Responsibilities
Develop and maintain SOPs, user manuals, validation protocols, and regulatory submission documents.
Translate complex scientific and technical concepts into clear, concise documentation.
Collaborate with SMEs to gather and verify technical information.
Ensure documentation complies with industry standards (GxP, ISO, ICH).
Author and execute validation protocols (IQ/OQ/PQ) for equipment, software, and processes.
Perform Computer System Validation (CSV) in accordance with 21 CFR Part 11 and GAMP 5.
Conduct risk assessments and support change control processes.
Review and approve validation documentation and reports.
#J-18808-Ljbffr