QA Compliance Pharmacist Assistant - Port Elizabeth 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