Job Title: Document Management Specialist
Role Overview:
The successful candidate will play a pivotal role in ensuring the accuracy and efficiency of document management processes, working closely with site production teams to maintain compliance with regulatory standards.
Key Responsibilities:
* Document Routing: Ensure timely routing of new and revised procedures, batch records, and compliance documents in the Quality Docs documentation management system.
* File Management: Maintain accurate filing systems for physical and digital records, adhering to storage protocols.
* Stakeholder Liaison: Coordinate with internal stakeholders to track and retrieve issued documents, facilitating timely returns.
* Document Preparation: Prepare documents for archiving, ensuring their integrity and authenticity.
* Record Maintenance: Review and maintain the accuracy of records, editing where necessary to ensure they remain up-to-date.
* Regulatory Compliance: Manage regulatory documents, guaranteeing their quality, integrity, and adherence to version control protocols.
* Document Uploads: Upload documents in line with site SOP's, utilizing appropriate templates.
* Data Integrity: Support data integrity by issuing, controlling, and reconciling procedural attachments.
* Error Tracking: Identify and highlight common documentation errors.
* Confidentiality: Maintain confidentiality regarding sensitive documentation.
* Audit Support: Assist on internal and external audits as required.
* Administrative Tasks: Perform ad-hoc tasks, including ordering stationery and maintaining printers, to support the Document Control team.
Requirements:
* Experience: A minimum of 3 years of experience working in a fast-paced administrative role.
* Interpersonal Skills: Strong interpersonal and communication skills, with a willingness to help others.
* Problem-Solving: Proven ability to deal with unexpected issues using problem-solving skills.
* Business Acumen: Proven interest in working within pharmaceutical production and understanding our business processes.
* Documentation Practices: Demonstrated good documentation practices and compliance with procedures.
* Self-Motivation: Self-motivation with the ability to operate without close supervision.
* IT Skills: Strong IT skills, including proficiency in the Microsoft Office Suite, experience with document management systems, PDF software, file naming, and version control.
* ISO Standards: Experience with ISO Standards is an advantage.
* Document Control: Previous experience in a Document Control role is desirable but not essential.
* Educational Qualifications: A Bachelor's degree is preferred; however, a Level 6 diploma in a relevant field is required.
Working Hours:
39 hours/week. Monday to Friday & occasionally some non-scheduled call-in time to respond to operational support issues.