QA Compliance Pharmacist Assistant

June 21, 2023

Aspen Pharma Group

Port Elizabeth

FULL TIME

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