Job Description
A Systems Specialist is needed to ensure the efficient execution, maintenance and continuous improvement of manufacturing documentation and digital systems. The role involves supporting electronic batch record systems and managing documentation workflows for compliant manufacturing operations.
The post holder will work with the manufacturing team to ensure essential elements are in place to allow operations run to scheduled timelines.
Key Responsibilities:
* Create, review and maintain manufacturing documents such as batch records, SOPs, MRSs and WI.
* E nsure documents are accurate, up-to-date and compliant with regulatory and internal standards.
* Coordinate document change control processes in collaboration with Quality Assurance.
* Act as a superuser or coordinator for digital manufacturing systems such as MES, ERP and DMS.
* Support system troubleshooting, user access management and training coordination.
* Ensure all documentation and system records are audit-ready and meet GMP and regulatory requirements.
* Support internal and external Quality, Safety and Regulatory audits by preparing documentation and responding to data requests.
* Participate in Quality and Safety and Regulatory audits as required.
* Track and implement CAPAs related to documentation or system issues.