Job Description
About the Company
KE Select are partnering with a growing organisation operating within a GMP-regulated pharmaceutical manufacturing environment supporting clinical-stage manufacturing and advanced therapeutic programs.
An opportunity is available for an experienced Documentation Specialist to support GMP documentation and validation activities across Quality and Technical Operations. This role will work closely with Validation, Quality, Manufacturing, and cross-functional SMEs to develop and maintain compliant documentation aligned with PIC/S, ICH, and TGA expectations.
Key Responsibilities
- Author and maintain validation protocols, reports, SOPs, specifications, and controlled GMP documentation
- Collaborate with Validation teams and SMEs to gather technical content and ensure documentation accuracy and compliance
- Support qualification and validation documentation activitie...