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