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 activities across GMP manufacturing operations
- Ensure documentation aligns with GMP, PIC/S, ICH, and internal quality system requirements
- Coordinate document review, revision, approval, and document control processes
- Support continuous improvement initiatives across documentation and quality systems
- Assist with audit and inspection readiness activities
About You - Degree qualification in Biotechnology, Pharmaceutical Science, Engineering, Microbiology, or related scientific discipline
- Experience authoring GMP validation documentation within pharmaceutical, biotechnology, or regulated manufacturing environments
- Strong understanding of GMP quality systems and validation lifecycle activities
- Exposure to validation protocols, qualification documentation, SOP development, and technical report writing
- Familiarity with PIC/S GMP requirements, ICH guidelines, and TGA expectations
- Strong technical writing skills with high attention to detail and document accuracy
Why Apply? - Technical GMP documentation and validation-focused role
- Exposure to advanced manufacturing and quality systems development
- Collaborative and fast-paced regulated manufacturing environment
How to Apply If you are seeking a technically focused GMP documentation opportunity within a growing pharmaceutical manufacturing environment, apply now or contact Ruby on 0481 200 171 for a confidential discussion.
KE Select are specialist recruiters across Life Sciences, Pharmaceuticals, Biotechnology, Medical Devices, and Clinical Research throughout ANZ, Asia, and the UK.
