SOP Technical Writer 120 (closed)
SOP Technical Writer
Write procedures for Cleaning, Compressed air, HVAC, Purified water, Commissioning and Qualification standards
Write SOP for risk based approach for determining requalification requirements.
Knowledge of current Good Manufacturing Practices and Regulatory guidelines for Pharmaceutical Industry.
Incorporate cGMP, Quality & Compliance standards into all phases of Operations where required
Some independent work will be necessary to gather information via interviewing/interacting with QSE personnel to author documents. Proofing created documents for formatting against a standard. Soliciting and incorporating feedback from QSE personnel into authored documents. Assuring authored documents are in compliance with Documentation Control and Training requirements. Obtaining the required training to be able to use all tools and aspects of the Enterprise Data Management (EDM) system.
The ability to work under strict time constraints and meet deadlines in a timely manner is required.
Minimumm of bachelor's degree in a science related field
Minimum 3 years experience (pharmaceutical or related industry experience preferred)
MS Office Skills, specifically Word, Excel, and Visio
• Ability to drive action
• Technical writing ability
• Ability to gather information, analyze and develop tactical plan
• Acts decisively, setting clear goals and objectives
• Demonstrated collaboration skills
• Drives accountability
• Must have ability to comprehend manufacturing processes, utilities and equipment
• Must have good verbal and written skills, and proven analytical ability
Less than 10%