Brief Description:

To support and control the management of controlled documents at the KSP facility.

To support complaints and supplier management within the QMS.

Essential Functions

Key Responsibilities / Accountabilities

• Control and issue of Issuing of Master Documents
• Allocation of Document numbers and maintenance of QA logs.
• QualDocs DCG User: creating DCCs, sending out controlled copies to internal/external file holders
• Creation, checking and storage of executed batch documents
• Controlling the GMP Archive area at KSP
• Dealing with DCG email requests
• Project support when required.
• Supplier / Vendor Change Management
• Collating metrics and KPI data
• Operates in accordance with the GW corporate values of being patient driven, passionate, innovative, collaborative, accountable, having integrity and achieving excellence
• The job holder is responsible for maintaining cGxP and H&S knowledge applicable to the job.
• The job holder must refer to the EHSS Policy (EHSS_P. 01) to understand the current EHSS responsibilities for the role.

Detailed responsibilities / Accountabilities

Control and Issuing of Master Documents.

• Logging, issuing, scanning, filing of master documents

Allocation of Document numbers and maintenance of QA logs.

• Generating new numbers when required and ensuring data is entered accurately.

Creation and storage of executed batch documents

• Creation of batch documents to Production areas for execution
• Checking of variable data within batch documents and confirming in NAV
• Archive of released batches in a timely manner to ensure they are secure

QualDocs DCG user

• Check of documents (when required) within QualDocs and creating Document Change Control within the system to allow documents to be approved/obsoleted.
• Identifying any controlled copies to be sent out to external/internal file holders
• Creation of execution copies.
• Maintenance of QualDocs system, ensuring documents are compliant and proceed through their lifecycles.
• Assisting users when required.

Control and maintenance of the GMP Archive area at KSP

• Retrieving documents from the Document Archive ensuring the control and maintenance of the archive area and checking the contents of all boxes submitted for archiving have been listed accurately.

Dealing with DCG email requests

• Emails sent to the DCG mailbox are to be actioned accordingly in a timely manner.

Project Support

• Supporting projects when required.

Supplier / Vendor Change Management

• Facilitates management of supplier / vendor change notifications throughout the business to ensure compliance of KSP processes is maintained.

Collating metrics and KPI data

• Weekly and monthly reporting of KPIs and metrics such as Off-site Archiving, DCC rejections, overdue documents.

AdHoc

• Can sign documents ('pp') on behalf of another Document Control Senior Coordinator and Document Control Coordinator in times of absence, and where experience allows.
• To perform duties or projects as required by Line Manager.
• Carries out their work in a way that will not adversely affect their own, or others', health, safety and security or the environment and reports any shortcomings in GW arrangements.
• Operates in accordance with the GW corporate values of being patient driven, passionate, innovative, collaborative, accountable, having integrity and achieving excellence
• Actively looks for improvements in productivity and efficiency within own work area
• Works in accordance with the systems in place with regards to health & safety, security and the environment
• Undertakes other activities, indirectly related or unrelated to the above listed accountabilities, as assigned by line manager/GQLT

Required Knowledge, Skills, and Abilities

Skills:

• Working knowledge of Microsoft Word and Excel.
• An organised approach to documentation with an eye for detail.
• Patience, ability to finish tasks and determination to see through tasks to the end.
• Education to secondary level or above. Ideally with a scientific background
• Good communication and person management skills are necessary.
• Knowledge in either GMP or in Quality Systems.
• Experience of being in Audit situations.

Attributes and Behaviors:

Proven organisational and interpersonal skills, demonstrated through the following competencies:

• Customer Focus: Is dedicated to meeting the expectations and requirements of internal and external customers; gets first-hand customer information and uses it for improvements in products and services.
• Integrity and Trust: Is widely trusted; is seen as a direct, truthful individual; can present the unvarnished truth in an appropriate and helpful manner; doesn't misrepresent him/herself for personal gain.
• Peer Relationships: Can quickly find common ground and solve problems for the good of all; can solve problems with peers with the minimum of noise; is seen as a team player and is cooperative.
• Functional/Technical skills: Has the functional and technical knowledge and skills to do the job at a high level of accomplishment.
• Time Management: Uses his/her time effectively and efficiently: concentrates his/her efforts on the more important priorities: gets more done in less time than others; can attend to a broad range of activities.
• Action Orientation: Enjoys working hard; is action orientated and full of energy for things he/she sees as challenging; not fearful of acting with a minimum of planning; seizes more opportunities that others.
• Organising:.