QS Business Supporter

Aspen Pharma Group • Other • Gqeberha, Eastern Cape, South Africa • 2w ago

QS Business Supporter
Aspen Pharma Group
2023-06-21 Port Elizabeth

Job Ref #: QABUS21
Industry: Manufacturing
Job Type: Permanent
Positions Available: 1

Applications are invited for the above indicated vacancy that exists in the Quality Systems department. The successful incumbent will report to the Quality Systems Manager. All applications are to be received on or before 27 June 2023 . Preference will be given to Employment Equity candidates in line with Aspen’s Transformation Agenda.

Job Description

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.

Job 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

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