QA Compliance Pharmacist Assistant

4 months ago

Port Elizabeth, South Africa Aspen Pharma Group 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 pr

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