Quality Assurance Pharmacist

Neoc Group Pty Ltd; Gauteng; On-site; ZAR 40 000 - 80 000; Full time

Job summary

An established industry player is looking for a Quality Assurance Pharmacist to ensure compliance with Good Manufacturing Practices (GMP) and oversee the Quality Management System (QMS). This role is crucial for maintaining high-quality standards and improving processes within the organization. The successful candidate will coordinate with various departments, conduct audits, and manage documentation to foster a strong quality assurance culture. If you have a Pharm degree, strong communication skills, and a passion for quality, this is an exciting opportunity to make a significant impact in the pharmaceutical industry.

Qualifications

• Registered with the South African Pharmacy Council.
• Minimum 5 years QA experience in pharmaceutical or medical devices.

Responsibilities

• Oversee Quality Management System and ensure compliance with regulations.
• Conduct internal and external audits and manage non-conformance documentation.

Skills

Strong communication skills

Ethical behavior

Teamwork ability

Deadline-oriented

Customer-focused

Detail-oriented

Good analytical skills

Education

Pharm degree

Tools

Document control systems

Quality Management Systems

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 current procedures comply with regulations for GxP.

The QA Pharmacist coordinates with other departments to foster a strong Quality Assurance culture throughout the company, continuously improving quality standards and providing guidance. This position also oversees all quality assurance arrangements and reports to senior management.

Job Summary

The Quality Assurance Pharmacist must understand the importance of an effective QMS and assist in its implementation to ensure 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 all 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, follow up on deviations. Liaise with service providers on QA matters. Manage non-conformance documentation and investigations. Support ADR processes. Conduct Root Cause Analysis (RCA) and implement CAPA. Manage Change Controls, validations, and Product Quality Reviews. Conduct QMR meetings. Ensure pest control programs are in place. Approve specifications 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 traceability of all distributed medicine batches for recall purposes.
4. RETURNED / REJECTED GOODS: Handle returned goods correctly and determine reasons for returns; decide on re-analysis, re-packaging, or destruction.
5. GMP / GWP / GHP: Perform 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 that all employees are trained to implement and maintain GxP and SOPs.

Knowledge & Experience

• Pharm degree, registered with the South African Pharmacy Council.
• Proficient in computer use.
• Knowledge of cGMP regulations.
• Bilingual in English and Afrikaans.
• Minimum 5 years QA experience.
• Experience with SOP and master QA document control.
• Understanding of South African regulatory environment.

Skills

• Strong communication skills.
• Ethical behavior.
• Teamwork ability.
• Deadline-oriented.
• Customer-focused.
• Detail-oriented with good analytical skills.