Documentation Engineer

Main Responsibilities:

1. 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, technical parameters, design drawings, and other relevant materials. Work closely with the Design and Validation departments to ensure document accuracy and technical compliance.

2. Revising Documents: Modify and update documents as needed based on customer review feedback.

3. Printing Documents: Ensure finalized documents are printed and delivered to the customer site in accordance with company procedures.

4. Regulatory Compliance: Familiarize with and adhere to isolator-related regulations and standards (GMP/ISO/ISPE, etc.) to ensure the legality and compliance of documents.

5. Communication Liaison: Establish effective communication with customers to understand their needs and provide professional technical support and consultation.

Job Requirements:

1. Bachelor's degree in Pharmaceuticals, Validation, or a related field.

2. Minimum 1 year of work experience, with QA experience in a pharmaceutical factory being mandatory.

3. Outgoing and proactive personality, with excellent communication skills and teamwork spirit.

4. Ability to work efficiently in a multitasking environment.

5. Preferred qualifications:

- Experience in document drafting.

- Experience in pharmaceutical equipment validation or equipment management.