Document Management Assistant

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 documentation management system

·       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.

·       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

Requirements:

·       A minimum of 3 years of experience working in a fast-paced, administrative role

·       Strong interpersonal and communication skills with a willingness to help others.

·       Proven ability to deal with unexpected issues using a problem-solving skill.

·       Proven interest in working within pharmaceutical production and understanding our business processes.

·       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 will be an advantage.

·       Previous experience in a Document Control role desirable but not essential

·       A Bachelor's degree is preferred; however, a Level 6 diploma in a relevant field is required.

Support Considerations:                                     

Working hours : 39 hours / week. Monday to Friday & occasionally some non-scheduled call-in time to respond to operational support issues.