POSITION DESCRIPTION:

• Management of GMP / controlled documentation across the Site to ensure that it remains up to date and in compliance with all relevant procedures.
• Act as the initial point source for any questions and/or support required relating to document creation/revision, training administration and Learning Plan management.
• Controlled printing and issuing of manufacturing documentation, including Batch Production Records Laboratory Workbooks and Production Logbooks to site.
• Provide business support to the areas assuring compliance with relevant Quality and EHS standards. Ensure business continuity.

MINIMUM QUALIFICATION (EDUCATION, EXPERIENCE AND/OR TRAINING, REQUIRED CERTIFICATIONS):

• Proficient in Microsoft Word, Excel and PowerPoint
• Experience in using Veeva Quality Doc and SuccessFactors

FUNCTIONS, DUTIES, TASKS:

Manage documents through the document management process. Activities include:

• Issuing documents according to periodic review schedule.
• Revising documents as and when requested by document owners or authors.
• Providing support to authors, assisting with formatting of documents, completion of forms such as Controlled Document Change Request Form.
• Track documents throughout the change process, liaising with authors to ensure target due dates for review and approval are met.
• Enforce rules between approval and effective dates for documents which need to be trained out.
• Make effective documents available to teams and (if required) controlled paper copies ready for collection and signing for.

Prioritising and supporting team and individual learning plans

• Conduct L&D induction for transfers and new starters to provide orientation around use of E-Learning system, re-prioritisation of Learning Plans, how to book instructor led training courses and working with Supervisors to ensure employees meet the 100% compliance.
• Maintain Learning plans by processing training records
• Assist Supervision with training metrics reports (as requested or agreed with local leadership) bringing any specific items of concern to their attention.

Systems/Process Support to team

• Use of electronic document management system (EDMS) for controlling documents and electronic quality management system for training record updates.
• Basic troubleshooting within EDMS.
• Assist document owners and authors to enable understanding of the process for creation/revision of controlled documents and associated training.

Filing and archiving of documents.

• Maintain paper files for documents as required, ensuring all appropriate documentation are filed appropriately.
• Assist in the maintenance of site archive as required in accordance with local SOP and provide support for document retrieval during audits

Printing of Batch Production Records and Laboratory Workbooks for the site. This activity will encompass the following tasks

• Ascertain the weekly demand for these documents
• Print check and bind the documents as required
• Log and issue documents to the appropriate departments

Control the issuing and retrieval of logbooks

• Maintain the Batch Production Record printing and archiving processes in a state of compliance
• Propose actions to rectify any issues raised work on their implementation

Continuous Improvement

• Assist in improvement activities to the document management and training process.

Embrace new technologies / systems designed to improve the document management and training process.