Overview
Our client, a leading biopharmaceutical company, is seeking a Documentation Specialist to support manufacturing operations and ensure the highest standards of quality, compliance, and efficiency.
Responsibilities
* Coordinate review, approval, and control of all manufacturing documentation (MBRs, SOPs, logbooks, labels).
* Ensure timely document progression in line with cGMP and site procedures.
* Support NPI, tech transfer, and routine manufacturing documentation readiness.
* Maintain strong compliance with GDP and GMP standards.
* Track key performance metrics and support continuous improvement initiatives.
* Act as a key contact for manufacturing and provide SME support on documentation processes.
Qualifications
* Bachelor’s Degree or equivalent preferential, preferably in a Science or related field
* 1+ years’ experience in a regulated manufacturing environment.
* Proven experience in document control and records management within GMP settings.
* Proficiency in Microsoft Word, Excel, PowerPoint, and electronic document management systems.
* Strong attention to detail and ability to meet tight deadlines.
For a confidential conversation about the role please apply for the role or contact Owen Clancy at oclancy@sterlingengineeringeu.com. By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose
#J-18808-Ljbffr