QS Business Supporter - Port Elizabeth at Aspen Pharma Group

Overview

• Execute daily tasks and work instructions according to the relevant SOP's.
• Operate computer systems by capturing data, printing standard reports, etc.
• Perform reconciliations of data
• Update and maintain databases
• Generate reports as per instruction
• Verify and interpret the accuracy of data and audit documentation
• Ensure that all relevant documentation gains the necessary signatures for completion
• Maintain accurate filing and retrieval of documentation
• Perform any other administrative tasks relating to your work as and when required

Responsibilities

Change Management

• Owner of the External Supply Change mailbox
• Timeous initiation of Trackwise® change controls for the External Supply Department
• Assignee role on external Supply Trackwise change control system which includes the below:
• Co-ordinating and completing the evaluation and/or pre-implementation requirements of the change
• Following up regularly and ensuring the change control record is completed within the required timeframe

Amendment Datapack Transfer to RA Registered Products Department

• Transferal and sending out notification of transfer of complete datapacks to RA Registered Products Department via required procedure as requested

SOPs and Training

• Assisting with update of required SOPs/ Work Instructions/ SFs for External Supply QMS functions which are relevant and up to date.
• Compiling work instruction or SOPs if gaps are identified or change in/new processes identified for the External Supply QMS functions
• Assist with training of ES Team on AQA Procedures
• Ensuring ES Team Training files are maintained
• Documentation Management
• Timeous uploading of relevant External Supply master documentation onto applicable Document Management System (Doc Compliance) and ensuring approval. This includes master documentation 
• received from the RA IP Department and RA Compliance Department.
• Ensuring all critical/required master documentation (or declarations) for the External Supply products are available

Reporting

• Sending out regular reports on the status of the External Supply change control/ deviation/CAPA system

General

• Pro-actively identifying simpler/more effective processes within the department without negatively impacting quality
• Consistently adhere to departmental procedures
• Reasonable requests and instruction timeously adhered to as requested by management.

Requirements
Requirements

Background/experience

• Matric/ Grade 12
• 2-3 years of experience in Pharmaceutical Manufacturing and Quality Assurance/Regulatory Affairs Environment
• Sound knowledge of Good Manufacturing and Good Documentation Practices
• Sound Knowledge of Quality Assurance
• Knowledge of Regulatory Affairs and product dossiers
• Computer literate