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.
Key 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.
Requirements:
* 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 By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose