Quality Assurance Pharmacist

Neoc Group Pty Ltd; Gauteng; On-site; ZAR 600,000 - 800,000; Full time

Job summary

A leading company is seeking a Quality Assurance Pharmacist to oversee the Quality Management System and ensure compliance with Good Manufacturing Practices. The role involves quality assurance functions, managing complaints, conducting audits, and training staff to maintain high standards in a regulated environment.

Qualifications

• Minimum 5 years of QA experience.
• Proficiency in computer literacy.
• Bilingual in English and Afrikaans.
• Knowledge of cGMP regulations.

Responsibilities

• Oversee Quality Management System (QMS) effectiveness.
• Manage QA functions including document control and audits.
• Ensure compliance with Good Manufacturing Practices (GMP).
• Handle product quality complaints and investigations.

Skills

Communication

Ethical principles

Teamwork

Deadline orientation

Customer focus

Attention to detail

Analytical skills

Education

Pharm degree and registration with the South African Pharmacy Council

Job description

Quality Assurance Pharmacist
Reference: JHB-Sines-3

Our client is seeking a Quality Assurance Pharmacist responsible for overseeing all key elements of the Quality Management System (QMS) and monitoring its effectiveness.

This role ensures that quality standards and procedures comply with GxP regulations.

The QA Pharmacist coordinates with other departments to foster a strong Quality Assurance culture, continuously improving quality standards and providing guidance. This position involves overseeing all quality assurance arrangements and reporting to senior management.

Job Summary: The Quality Assurance Pharmacist must understand the importance of an effective QMS and assist in its implementation to ensure ongoing compliance with Good Manufacturing Practices (GMP) regulations.

An effectively maintained QMS leads to streamlined processes and cost savings.

Duties & Responsibilities

1. QUALITY ASSURANCE: Review, revise, update, and authorize departmental SOPs. Manage QA functions including document control, Site Master File, Quality Manual, and Quality Policy. Implement the Validation Master Plan. Approve and manage the approved supplier list. Conduct internal and external audits and follow up on deviations. Liaise with service providers on QA matters. Manage non-conformance documentation and investigations. Support Adverse Drug Reaction (ADR) processes. Conduct Root Cause Analysis (RCA) and implement CAPA. Manage Change Controls, validations, and Product Quality Reviews. Conduct Quality Management Review meetings. Ensure pest control programs are in place. Approve specification sheets for release. Ensure Technical Quality Agreements with third-party contractors. Implement a Stability Master Plan. Experience in Medical Devices is desirable.
2. COMPLAINTS: Ensure all product quality complaints are identified, investigated, and addressed appropriately.
3. RECALLS: Ensure batch traceability of distributed medicines for recalls.
4. RETURNED / REJECTED GOODS: Handle returned goods correctly and determine reasons for returns. Make final decisions on re-analysis, re-packaging, or destruction.
5. GMP / GWP / GHP: Perform inspection audits on third-party contractors. Ensure compliance with GMP and manufacturing procedures. Ensure proper handling and storage of products. Conduct internal audits.

Secondary Duties

Training: Monitor training of all employees to implement and maintain GxP standards and SOPs.

Knowledge Required

• Pharm degree and registration with the South African Pharmacy Council.
• Proficiency in computer literacy.
• Knowledge of cGMP regulations.
• Bilingual in English and Afrikaans.

Experience Required

• Minimum 5 years of QA experience.
• Experience in SOP and master QA document control.
• Understanding of South African regulatory environment.

Skills Required

• Strong communication skills.
• Ethical principles and behavior.
• Ability to work in a team.
• Deadline orientation.
• Customer focus.
• Attention to detail.
• Good analytical skills.