Documentation Engineer

As a Document Specialist, your role involves drafting, revising, and printing various documents essential for the design, assessment, validation, and manuals based on technical parameters and design drawings. You will work closely with the Design and Validation departments to ensure document accuracy and technical compliance. Your key responsibilities include: - Drafting Documents: Prepare and update design documents (FS/DS/HDS/SDS), assessment documents (C/FRA/EMRA/ERES/EMRA, etc.), validation documents (FAT/SAT/IQ/OQ/PQ), and manual documents (OM/MM/SM) based on URS, task specifications, and other relevant materials. - Revising Documents: Modify and update documents based on customer review feedback to ensure accuracy and compliance. - Printing Documents: Ensure finalized documents are printed and delivered to the customer site following company procedures. - Regulatory Compliance: Familiarize with isolator-related regulations and standards (GMP/ISO/ISPE, etc.) to ensure legal compliance of documents. - Communication Liaison: Establish effective communication with customers to understand their needs and provide technical support and consultation. Qualifications Required: - Bachelor's degree in Pharmaceuticals, Validation, or a related field. - Minimum 1 year of work experience, with mandatory QA experience in a pharmaceutical factory. - Outgoing and proactive personality with excellent communication skills and teamwork spirit. - Ability to work efficiently in a multitasking environment. Preferred qualifications: - Experience in document drafting. - Experience in pharmaceutical equipment validation or equipment management. This role offers the opportunity to work collaboratively with various departments, ensuring the accuracy and compliance of essential documents while providing professional technical support to customers.,