Principal Quality Assurance Specialist (Pharmaceutical)

Placements24; Johannesburg; Hybrid; ZAR 1,200,000 - 1,900,000; Full time

Benefits offered by this job

Health insurance

Retirement plan

Paid time off

Job summary

Placements24 is seeking a Principal Quality Assurance Specialist to lead quality initiatives for a pharmaceutical client operating remotely with occasional site visits to Randburg, Gauteng. This senior role focuses on building and sustaining a robust QMS, driving audits, and assuring regulatory compliance across global guidelines.

The ideal candidate brings 10–12+ years in pharma QA/QC, strong CAPA expertise, and exceptional communication skills to influence a quality culture in a remote-first

Qualifications

• Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or related field.
• 10–12+ years of progressive experience in Pharmaceutical Quality Assurance/Quality Control.
• Deep knowledge of cGMP, GDP, FDA/EMA/SAHPRA guidelines.
• Proven experience with audits and CAPA systems.
• Strong communication and leadership in remote settings.

Responsibilities

• Develop and manage the Quality Management System (QMS) for pharmaceutical operations.
• Lead internal audits and external audits of suppliers, contract manufacturers, and partners.
• Review and approve SOPs, validation protocols, batch records, and change controls.
• Investigate deviations, non-conformances, and customer complaints, implementing CAPAs.
• Ensure compliance with cGMP, ICH guidelines, and all applicable regulations.
• Provide training on quality assurance principles to internal teams.
• Participate in regulatory inspections and manage responses to authorities.
• Lead continuous improvement initiatives to enhance product quality.
• Monitor and report on quality metrics to senior management.
• Contribute to risk assessment and management for products and processes.
• Travel to Randburg, Gauteng facilities as needed.

Skills

Audits

QA Leadership

Regulatory Knowledge

CAPA process

Documentation Review

Analytical Thinking

Remote Team Influence

Problem Solving

Education

Pharmacy degree

Science degree

Tools

eQMS software

Job description

About the Role

Our client, a respected pharmaceutical company dedicated to quality and compliance, is seeking an accomplished Principal Quality Assurance Specialist to join their expanding team, operating remotely with potential for occasional site visits to Randburg, Gauteng .

This senior-level role is crucial for ensuring that all pharmaceutical products meet the highest standards of safety, efficacy, and regulatory compliance. The Principal QA Specialist will be responsible for developing, implementing, and maintaining the company's Quality Management System (QMS), conducting internal and external audits, and providing expert guidance on quality-related matters. This position demands a profound understanding of global regulatory landscapes, including FDA, EMA, and local South African regulations. We are looking for a proactive, detail-oriented professional with a strong ethical compass and the ability to influence quality culture across the organization. This is a fantastic opportunity for an experienced QA professional to lead initiatives and drive quality excellence in a remote-first capacity.

Key Responsibilities

• Develop, implement, and manage the comprehensive Quality Management System (QMS) for pharmaceutical operations.
• Conduct regular internal audits and lead external audits of suppliers, contract manufacturers, and partners.
• Review and approve key quality-related documents, including SOPs, validation protocols, batch records, and change controls.
• Investigate deviations, non-conformances, and customer complaints, implementing corrective and preventive actions (CAPAs).
• Ensure compliance with cGMP, ICH guidelines, and all applicable international and local pharmaceutical regulations.
• Provide expert guidance and training on quality assurance principles and regulatory requirements to internal teams.
• Participate in regulatory inspections and manage responses to regulatory authorities.
• Lead continuous improvement initiatives aimed at enhancing product quality and process compliance.
• Monitor and report on key quality metrics and performance indicators to senior management.
• Contribute to the risk assessment and management processes for products and processes.

Requirements

• Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related scientific field.
• Minimum of 10-12 years of progressive experience in Pharmaceutical Quality Assurance/Quality Control.
• Extensive knowledge of cGMP, GDP, and relevant pharmaceutical regulatory guidelines (FDA, EMA, SAHPRA).
• Proven experience in conducting internal and external audits and managing CAPA systems.
• Strong understanding of pharmaceutical product lifecycle and manufacturing processes.
• Excellent document review and approval skills, with exceptional attention to detail.
• Superior analytical, problem-solving, and critical thinking abilities.
• Outstanding written and verbal communication and interpersonal skills.
• Demonstrated ability to lead and influence teams in a remote work setting.
• Experience with electronic QMS (eQMS) software is highly desirable.

Benefits

Our client offers a competitive salary, comprehensive benefits package including health, dental, and vision insurance, a retirement savings plan, and generous paid time off. As a Principal QA Specialist operating remotely, you will enjoy the flexibility of working from home while contributing to critical quality functions for a respected pharmaceutical organization. We provide opportunities for continuous learning and professional growth, fostering an environment where your expertise in quality assurance is valued and impactful. Opportunities for occasional travel to our Randburg, Gauteng facilities may arise for critical meetings or audits.