GMP Documentation Specialist / Technical Writer (M/F/D)

GMP Documentation Specialist / Technical Writer (M/F/D) Tasks: Author, revise and format GMP documents (SOPs, work instructions, batch records, protocols, reports) in line with internal and regulatory requirements Ensure technical accuracy, clarity, and compliance with cGMP and GxP standards Collaborate closely with SMEs across Manufacturing, QA, QC, MS&T, and Engineering to capture and structure process information Coordinate and facilitate document reviews, incorporating feedback while maintaining document control and version integrity Manage the full document lifecycle (drafting, review, approval, periodic review, archival) Handle document routing and compliance within eQMS systems (e.g., Veeva, MasterControl), ensuring proper formatting and change control Support audit readiness and continuously improve documentation processes Qualifications: Several years of experience in GMP documentation within pharma or biotech environments Strong knowledge of cGMP and GxP regulations Hands‑on experience with SOPs, batch records, work instructions, protocols, and reports Proficiency with eQMS systems (e.g., Veeva, MasterControl or similar) Solid understanding of document control and lifecycle management Experience working cross‑functionally with technical teams Structured, detail‑oriented working style with strong communication skills Familiarity with regulatory requirements (FDA, GxP) #J-18808-Ljbffr