Technical Writer Job

#Hiring

Job Title : #Technical #Writer/ #Validation #Specialist (#Life #Sciences) Location : #West #Point, #PA (#Hybrid) (#Local Only) Hire Type : #Contract

Job Description :     Develop and maintain #SOPs, user #manuals, #validation protocols, and #regulatory #submission documents. Translate complex scientific and technical concepts into clear, concise #documentation. Collaborate with #SMEs to gather and verify technical information. Ensure documentation complies with industry standards (#GxP, #ISO, #ICH). Manage document lifecycle using #electronic #document #management #systems (#EDMS). Author and execute validation protocols (#IQ/ #OQ/ #PQ) for equipment, software, and processes. Perform #Computer #System #Validation (#CSV) in accordance with #21 #CFR #Part #11 and #GAMP 5. Conduct risk assessments and support change control processes. Review and approve validation documentation and reports.

Regards, Shyam Pachouri shyam@msrtechnologies.com