QA Compliance Pharmacist Assistant

Aspen Pharma Group; Gqeberha; On-site; ZAR 50,000 - 200,000; Full time

Job summary

A leading pharmaceutical company in Gqeberha is looking for a Pharmacist Assistant. The role involves monitoring compliance with GMP, managing daily operations related to data logs, and handling customer complaints. Candidates must have a Matric qualification and a Post-basic Pharmacist Assistant Certification, along with proficiency in MS Word and Excel. The position offers opportunities for continuous improvement within a professional environment.

Qualifications

• Matric / Grade 12 qualification required.
• Required to have a Post-basic Pharmacist Assistant Certification.
• Proficiency in MS Word and Excel is essential.

Responsibilities

• Monitor compliance with GMP and statutory requirements.
• Execute daily tasks and work instructions.
• Manage customer complaints and coordinate investigations.
• Maintain and review management system metrics.

Skills

Attention to Detail

Data Management

Problem Solving

Team Collaboration

Education

Matric / Grade 12

Post-basic Pharmacist Assistant Certification

Tools

MS Word

MS Excel

Job description

Overview

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

Responsibilities

1. General Operation Activities

• Execute daily tasks and work instructions according to the relevant SOPs.
• Operate computer systems by capturing data, printing standard reports, etc.
• Perform reconciliations of data.
• Update and maintain databases.
• Edit and format SOPs as required.
• Generate reports as per instructions.
• Verify and interpret the accuracy of data and audit documentation.
• Ensure all relevant documentation gains necessary signatures for completion.
• Maintain accurate filing and retrieval of documentation.
• Perform any other work-related tasks as required.

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

• Review of COAs, product samples, and artwork for GMP and registered information compliance.
• Monitor blocked stock at various warehouses; ensure product review per SOP for SA and International Markets.
• Manage special product investigations such as AQLs at Aspen warehouses by QA.
• Review data logger downloads for products received and highlight non-conformances to QA management.
• Update daily blocklist regarding sample and data logger review status.
• Provide feedback to Logistics, Marketing, and other internal customers regarding product status in QA.

Management of data loggers and temperature excursions

• Daily checks of temperature readings in Reference Sample rooms; escalate Out-of-specification results.
• Monthly download of temperature readings for Pharmacist review and approval.
• Order data loggers as needed for Reference Sample rooms and External Supply shipments.
• Log and track data logger information in databases.
• Download data from received data loggers and save appropriately.
• Return data loggers to manufacturers for downloading when required.
• Log all temperature excursions and ensure proper evaluation.
• Assign excursions to Pharmacists for evaluation.
• Assist with related queries.

Management of Item Masters

• Maintain item masters on Baan system; ensure use of tracking and authorization documents.
• Contribute QA input for Baan system upgrades.
• Control changes to item masters via Change Control process.
• Review item masters periodically for accuracy and gaps; initiate change controls as needed.

Management of NPS Requisitions

• Initiate NPS requisitions on Baan for PIT, data loggers, standards, consumables, etc.
• Ensure accuracy and timely actioning of requisitions.
• Provide necessary information for approval.

Customer Complaints Coordination

• Log complaints received from customers.
• Coordinate investigation with Contract Manufacturer as per assessment.
• Follow up with suppliers on complaint status.
• Maintain complaint records and reports.
• Assist with related queries.

QMS Metrics and Change Management

• Review and initiate SOPs, deviations, and stand-alone events.
• Log and manage deviations and change controls effectively.

Continuous Improvement

• Identify process gaps and propose improvements.
• Manage projects as per guidelines and timelines.
• Report progress and issues regularly.

Human Resources and Compliance

• Ensure compliance with Labour Laws and company policies.
• Follow GMP/GLP requirements and maintain accurate records.

Health, Safety, and Environment

• Comply with OHS Act and report unsafe situations or incidents.

Requirements

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