Current Opportunities at Aspen Pharma Group

Description
Overview

• Monitor manufacturing compliance to GMP and statutory requirements.
• Monitor adherence to guidelines, procedures, and document controls.
• Related support and administrative tasks.

Responsibilities
General Operation Activities

• 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
• Edit and format SOP’s as and when required.
• 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 tasks relating to your work as and when required.

Review of all External Supply Products (i.e. COA, samples & dataloggers) as part of the release process

• Review of COA’s, product samples and artwork for compliance to GMP and registered information.
• Monitoring blocked stock at the different warehouses on continuous basis
• Ensure product review is conducted as per SOP for SA and International Markets.                                            
• Management of special product investigations such as AQL’s to be performed at the Aspen warehouses by the QA team.
• Review of data logger downloads for product's received in country and highlighting any non-conformances to the QA management team.  
• Updating of the daily blocklist regarding status of the sample and data logger reviews of each batch.
• Providing feedback and communication to Logistics, Marketing, and other relevant internal customers, regarding status of products in QA.

Management  of  data loggers and temperature excursions

• Daily checks of temperature readings within the Reference Sample rooms and escalation of any Out-of-specification results to QA Management.
• Monthly download of temperature readings of the Reference Sample rooms for Pharmacist review and approval.
• Ordering of data loggers as required for use in the Reference Sample rooms as well as External Supply (ES) shipments.
• Logging and Tracking data logger information in the relevant databases.
• Downloading of data loggers received with shipments and saving it in the relevant folders.
• Where required, returning of data logger to the manufacture for downloading.
• Logging of all Temperature Excursions on the relevant database and Trackwise system.
• Ensuring that all the relevant information is received for proper evaluation of the excursion.
• Allocation of the temperature excursion to a Pharmacist for evaluation.
• Assisting with queries, where applicable.

Management of Item Masters

• Ensure the adequate creation and maintenance of item masters on the Baan system (Baan LN & Baan 441) and the use of the relevant tracking/authorisation documents.                      
• Provide QA input into Baan projects for the effective setup of Baan (software) upgrades.
• Ensure changes to the Item masters are controlled via the Change Control process.
• Periodically review the item masters for accuracy and gaps, initiate change controls where changes are required to ensure greater compliance.

Management of NPS Requisitions

• Initiation of Non-Product Spend (NPS) requisitions on the Baan system for Post Importation Testing (PIT), data loggers, reference standards, consumables, etc. as and when required.
• Ensuring that the NPS requisitions are accurate and actioned timeously to prevent delays in QA processes.
• Provide the NPS requisition approver with the necessary information for review and approval.

Co - ordination and tracking of customer complaints for External Supply Manufacturers

• Loggings of complaints on relevant spreadsheet as customer complaints are received.
• Based on assessment from Pharmacist, send complaints and samples (if applicable) to Contract Manufacturer (CM) for investigation.
• Regularly follow up with suppliers on status of open complaints.
• Update/ Maintain relevant spreadsheets on a regular basis.
• Save customer complaints information and reports on the relevant folders.
• Assisting with queries regarding customer complaints, where applicable.

QMS Metrics; SOP’s, deviations, stand alone events and actioning of change control actions.

• Initiation and Review of SOPs and Work Instructions relevant to work function.                                                                   
• Timeous logging of internal and external deviations on the Trackwise system and management thereof.
• Ensuring that the relevant deviation spreadsheets and folders are updated as required.
• Completion of action items assigned to you on Change Controls logged on Trackwise and Process Compliance.
• Initiation and tracking of Stand Alone Events to completion

Continuous Improvement Initiatives

• Identify gaps within the current processes and investigate and propose ways to close those gaps.
• Identifying ways to streamline processes, resulting in quicker turnaround of QA activities.
• Manage projects assigned to you as per guidelines from the manager and as per agreed timeframes.
• Regularly provide feedback on progress of projects and highlight any issues that require manager’s attention.

Human Resources

• Compliance to Labour Legislations and In-house Best Practice).
• Familiarise yourself with and at all times act in accordance with the company policies and procedures

GMP Compliance

• Complete all records and reports timeously and accurately as described in the relevant SOP’s, protocols and associated documentation.
• Comply with GMP/GLP requirements as outlined by company SOP’s and written instructions in all tasks and activities.
• Ensure that products are handled according to the required SOP’s and documentation.

Health, Safety and Environmental Standard

• Carry out any duty or requirement imposed on the company by the OHS Act and in accordance with your specific SHE appointment
• Report any unsafe or unhealthy situations to SHE representative or Line Manager
• Report any incident to the SHE representative or Line Manager which may affect your health or cause injury

Requirements

• Matric / Grade 12
• Post-basic Pharmacist Assistant Certification
• Computer Literate – MS Word & Excel

Requirements
Requirements

• Matric / Grade 12
• Post-basic Pharmacist Assistant Certification
• Computer Literate – MS Word & Excel

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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

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Objective: 

• To promote and generate sales on key product portfolios to pharmacies on both ethical and generic ranges. In addition to mentioned objective, the position will also be responsible for building and maintaining strong business relationships with pharmacy decision makers, in order to drive net sales revenue.

KEY RESPONSIBILITIES

• Achieve and exceed set sales targets and market share objectives.
• Effective implementation of sales and marketing strategies.
• Effective management of the regional territory by means of planning, territory analysis, customer targeting and call coverage of identified customer base.
• Establishment of positive relationships (mutual trust and respect) with customers and other stakeholders.
• Manage key customer sales and effective relationship management.
• Providing ongoing customer support.
• Add value to an entrepreneurial climate.
• Effective territory expense management and control.
• Active engagement with team members & piers in order to build an exciting and high-performance team and company culture.

Requirements

 SKILLS AND KNOWLEDGE

• Product knowledge on both Aspen and competitor products.
• Effective territory management.
• Knowledge of basic financial calculation i.e. Gross Margins, mark-ups.
• Analysing of Aspen in house data and external data sources.
• Strong ability to effectively communicate with both internal and external customers.
• Administration skills – ability to comply with the required administration standards associated with this position.
• Ability to work under pressure, to set priorities and to demonstrate time management skills.
• Creativity and flexibility – the ability to work in a changing environment and to adapt to different situations.

EDUCATION & EXPERIENCE

• Matric qualification.
• Tertiary qualification would be advantageous.
• 1-2 years proven sales track record is essential.
• Previous basket experience/exposure would be an advantage.
• Valid driver’s license and own vehicle.
• Existing relationships with key customers in the territory would be advantageous.