Quality Assurance Pharmacist Midrand

Neoc Group Pty Ltd; Gauteng; On-site; ZAR 30 000 - 60 000; Full time

Job summary

Ein etabliertes Unternehmen sucht einen Quality Assurance Pharmacist, der für die Überwachung des Qualitätsmanagementsystems verantwortlich ist. Diese spannende Rolle erfordert die Implementierung und Einhaltung von GMP-Vorschriften, sowie die Durchführung von Audits und Schulungen. Der ideale Kandidat sollte über ein Pharmadiplom verfügen und in der Lage sein, in einem dynamischen Umfeld zu arbeiten. Diese Position bietet die Möglichkeit, die Qualitätssicherung zu verbessern und einen positiven Einfluss auf die Unternehmensstandards zu haben. Wenn Sie eine Leidenschaft für Qualität und Compliance haben, könnte dies die perfekte Gelegenheit für Sie sein.

Qualifications

• Abgeschlossenes Pharmastudium und Registrierung beim South African Pharmacy Council.
• Kenntnisse über cGMP-Vorschriften und das südafrikanische regulatorische Umfeld.

Responsibilities

• Überwachung und Genehmigung von SOPs sowie Durchführung interner und externer Audits.
• Verwaltung von Qualitätsmanagementsystemen und Schulung der Mitarbeiter in GxP.

Skills

Kommunikationsfähigkeiten

Analytische Fähigkeiten

Detailorientierung

Teamarbeit

Education

Pharmadiplom

Tools

Dokumentenmanagementsysteme

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 as needed.

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).

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 and manage Validation Master Plan.
• Approve and oversee supplier approval lists.
• Conduct internal and external audits, follow up on deviations.
• Coordinate with service providers on QA matters.
• Handle non-conformance documentation and investigations.
• Support Adverse Drug Reactions (ADR).
• Perform Root Cause Analysis (RCA).
• Implement Corrective and Preventive Actions (CAPA).
• Manage Change Controls, process and method validations, and product quality reviews.
• Conduct Quality Management Review (QMR) meetings.
• Ensure pest control programs are in place.
• Approve specification sheets for release.
• Establish Technical Quality Agreements with third-party contractors.
• Implement a Stability Master Plan.

1. Product Complaints & Recalls:

• Investigate and resolve product quality complaints.
• Ensure batch traceability for recalls and proper documentation of returns/rejections.

1. GMP/GWP/GHP Compliance:

• Perform inspections on third-party contractors to ensure GMP compliance.
• Verify manufacturing operations meet specifications and are properly documented.
• Ensure storage, transport, and distribution comply with quality standards.
• Maintain logs related to temperature, cleaning, and maintenance.
• Oversee disposal and destruction of medicines.
• Ensure pest control measures are in place.
• Conduct internal and external audits, including on arrival and before release.
• Provide ongoing GMP training to employees.

Secondary Duties

• Training: Monitor staff training on GxP and SOPs across departments.

Knowledge & Experience Requirements

• Pharm degree, registered with the South African Pharmacy Council.
• Proficient in computer skills.
• Knowledge of cGMP regulations and South African regulatory environment.
• Bilingual in English and Afrikaans.

Skills

• Strong communication and ethical principles.
• Ability to work collaboratively and supportively.
• Deadline-oriented, customer-focused, and detail-oriented with good analytical skills.
• Ability to work under pressure.