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Technical writer || Pharma/Bioscience Industry
2 months ago
Onsite role
These are the TOP 3 Requirements for a candidate to be considered for this role.
Experience writing Standard Operating Procedures, Work Instructions/Practices, and Risk Assessments for pharmaceutical production processes and/or manufacturing equipment, systems, utilities, and facilities.
• Preferred experience authoring and executing commissioning/qualification/validation deliverables including plans, system requirements, protocols, traceability matrices, and summary reports.
• Minimum 5 years of experience in technical writing, with 3 years of technical writing experience in the pharmaceutical industry
2. REQUIRED COMPETENCIES:
Knowledge, Skills & Abilities:
• Excellent technical writing skills and proficiency with Microsoft Word formatting functions; ability to efficiently create technically accurate documents for system lifecycle deliverables in alignment with the site validation program; highly attentive to spelling, grammar, punctation, and overall document quality.
• Process oriented with solid critical thinking skills; adaptive and able to develop new/improved strategies, approaches, and procedures.
• Strong understanding of cGXP requirements and good documentation practices relating to systems, equipment and instrumentation within the pharmaceutical industry.
• Experience writing Standard Operating Procedures, Work Instructions/Practices, and Risk Assessments for pharmaceutical production processes and/or manufacturing equipment, systems, utilities, and facilities.
• Preferred experience authoring and executing commissioning/qualification/validation deliverables including plans, system requirements, protocols, traceability matrices, and summary reports.
• Preferred experience writing protocol deviations, investigating out of specification results, performing corrective and preventive actions, and executing change controls.