Senior Qa&Ra Specialist

Salesworx Recruitment (Pty) Ltd; Gauteng; On-site; ZAR 600 000 - 700 000; Full time

Job summary

A leading recruitment agency has an opening for a Senior QARA Specialist in Gauteng, South Africa. The role involves ensuring compliance with quality assurance processes, managing local regulatory requirements, and supporting quality activities across different functions. Candidates should have a Pharmacy Degree, with at least 3 years of relevant experience and fluency in English and Afrikaans. The position offers a basic salary and travel allowance.

Benefits

Basic salary

Travel allowance

Qualifications

• At least 3 years of professional experience in quality and regulatory fields.
• At least 2 years of experience as a Pharmacist.

Responsibilities

• Ensure RA processes are in place and compliant with regulations.
• Maintain good standing with local regulators and manage regulatory activities.
• Support Quality activities of the Third-Party Logistics Warehouse.

Skills

Stakeholder liaison

Knowledge of GMP

Knowledge of GDP

Fluent in English and Afrikaans

Stress resistance

Excellent communication skills

Organisational skills

Team player

Self-motivated

Education

Pharmacy Degree

Job description

Role Overview

Senior QARA Specialist – 6 month temp contract with the view to permanent employment at the end of the period.

The role of Senior QARA Specialist is responsible for ensuring that CQA processes are in place in his / her region: Local Complaint Coordinator activity, Product Surveillance activity for Medicinal Products and Medical Devices, Field Action execution, Supplier & Distributor Management: Implementation of Quality System in the region and audit management, NCR, CAPA and Change Management, Selling Authorizations and release of products according to local requirements. Ensure back up persons for critical processes in the region are appropriately trained and back up are always available. To ensure that processes and procedure related to mentioned activities are compliant to local regulations, to the Corporate Quality Manual and to ISO requirements.

Key Responsibilities

• Ensure RA processes are in place in his / her region: proactively monitor, review, interpret, and translate all national regulatory requirements of the Medicines Regulatory Authority and develop and implement strategies for earliest possible regulatory approvals to support business plans.
• Maintain a good standing with the local regulators and effectively manage the regulatory activities in line with the company expectations.
• Ensure appropriate contacts with country Supply Chain, Pharmacovigilance, TS, W&D and Businesses are maintained.
• As Deputy Pharmacist of entity in South Africa: ensure company compliance with the Medicines and Related Substances Act and the Pharmacy Act and cGMP in the control of medicines and medical devices distributed and sold.
• Support the Quality activities of the Third-Party Logistics Warehouse in South Africa.
• Local Complaint Coordinator: ensure a process and procedures are in place for the logging and investigation of complaints, notify the authorities of reportable Complaints, train the customer facing employees on complaints handling Process, close complaints with Customers and Authorities, and ensure backup LCC are appropriately trained.
• Country Product Surveillance activity for Medical Devices: ensure effective gathering, recording, transmission to the Product Surveillance team and reporting to the competent Authorities of medical device adverse events, collect, follow‑up, transmit all local incidents and near incidents to CTPS using the Global tracking system and archive relevant documents.
• Set up and maintain an efficient Product Surveillance system in compliance with national medical device regulations and employer standards, and maintain appropriate contacts with other functions such as Technical Services, Sales and Marketing.
• Manage and execute Field Corrective Actions: act as local FA Coordinator, ensure execution of FAs according to Corporate, EMEA and local Procedures, communicate with MOH and customers, ensure timely execution, reconciliation, and closure of FAs, and ensure backup local FA Coordinators are trained.
• Distributor Control: manage the distributor / Third parties' assessment program, perform and document Third Party audits, supervise corrective actions, train distributors on QMS requirements, and sign QA agreements defining responsibilities.
• Supplier QA: manage the supplier QA program of sponsoring Divisions for products and parts sourced in the region, prepare for internal and external assessments, conduct auditors, and manage training and documentation.
• Training: ensure systems are in place to train employees in quality system compliance (including new SOPs), maintain training records, and ensure distributors and service providers are trained on GDP and company requirements.
• QMS & Documentation: implement applicable SOPs in the region, ensure all relevant SOPs are in place to meet Corporate Quality Manual requirements and ISO standards, manage SOP preparation, distribution, obsoleting, and filing of quality documents.
• NCR, CAPA and Change Management: initiate and investigate NCR in the region, implement corrective and preventive actions, manage the Change Control process, and ensure timely approvals of post‑registration variations.
• Winning Authorizations: ensure products are sold only to authorized entities, comply with local regulations, and certify release of products in accordance with local requirements.
• ERP System SME: become an expert of distribution related aspects of JDE and other ERPs, ensure backup for ERP expert user functions.
• Temperature‑controlled shipments: manage quality aspects, maintain and train backups of critical tasks (PQCs, MDRs, FAs, Releases).
• Third‑party warehouses: define and control quality aspects, establish and maintain sample rooms where required.
• Regulatory Affairs: deliver annual product submission plan, compile and oversee submission of dossiers, due diligence on prospective dossiers, deliver future registrations, liaise with Regulatory Authorities, and coordinate GMP / GCP inspections.
• Control correspondence with other pharmaceutical companies and consultants with regards to regulatory activities.

Required Skills and Qualifications

• Ability to liaise with internal and external stakeholders: Pharmacovigilance, W&D, Supply Chain, Compliance, Technical Services, Business, Regulatory Authorities, Third Party partners.
• Good Knowledge of GMP, GDP, ISO.
• Fluent in English and Afrikaans.
• Stress resistance and ability to work in a rapid response environment.
• Excellent communication skills, both verbal and written.
• Good organisational skills and the ability to multitask.
• Strong listening skills; strong team player with a flexible approach yet able to work unsupervised under pressure.
• Self‑motivated with a high level of initiative.
• Experience: at least 3 years professional experience in quality and regulatory fields, and at least 2 years as Pharmacist.
• Education: Pharmacy Degree required.

Benefits

Basic salary and travel allowance.