Document Management Assistant

Document Management Assistant Team: Small Molecule Documentation Control

The Document Management Assistant will assist in management of production batch records, GMP documentation and electronic systems associated with the site production teams.

Key Deliverables:

• Routing of new and revised procedures, batch records and compliance documents in Quality Docs.
• File documents in physical and digital records and ensure appropriate storage. Liaise with internal stakeholders to track and retrieve issued documents for timely return. Preparing these documents for archive
• Review and maintain the accuracy of the records, editing where necessary to ensure they are up to date
• Management of regulatory documents, ensuring their accuracy, quality and integrity and compliance with version control
• Upload documents in line with site SOP's - appropriate templates used etc.,
• Routing of new and revised procedures, batch records and compliance documents in Quality Docs documentation management system
• Supporting Data Integrity- specifically the issuing, controlling and reconciling of procedural attachments.
• Track documentation errors and highlight common problem areas.
• Maintain confidentiality around sensitive documentation
• Assist on internal and external audits
• Ad-hoc tasks - ordering stationary, maintaining printers, or any other tasks related to supporting the Document Control team

Key attributes required to successfully deliver the support required:

• Proven interest in working within pharmaceutical production and understanding our business processes.
• Strong interpersonal and communication skills with a willingness to help others.
• Proven ability to deal with unexpected issues using problem-solving skills.
• Demonstrated Good Documentation Practices and compliance with procedures.
• Self-motivation with the ability to operate without close supervision.
• Strong IT skills:
  • Proficiency in the Microsoft Office Suite,
  • Experience with Document Management Systems,
  • PDF Software
  • File naming and version control,
  • Basic troubleshooting,
  • Database entry,
  • Workflow configurations
• Experience with ISO Standards
• A minimum of 3 years of experience working in a fast-paced, administrative role
• Previous experience in a Document Control role desirable but not essential
• Completed Level 6 diploma in a related discipline is essential. Bachelor's degree in a related field is desirable.

Support Considerations:

Monday to Friday and occasionally some non-scheduled call-in time to respond to operational support issues.