Pharmaceutical Quality Assurance Officer

Placements24; Randburg; Hybrid; ZAR 520,000 - 800,000; Full time

Benefits offered by this job

Medical aid

Retirement fund

Professional development

Hybrid work model

Performance bonuses

Job summary

Placements24 is seeking a Pharmaceutical Quality Assurance Officer for their Randburg, Gauteng facility. This hybrid role combines on-site QMS oversight with remote data analysis, focusing on regulatory compliance, cGMP, and product quality throughout the lifecycle.

You will lead internal audits, review batch records, manage deviations and CAPA, and contribute to continuous improvement. A Bachelor's in Pharmacy/ Chemistry/ Biotechnology and 3–5 years' QA/QA experience are required, with strong

Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Biotechnology, or a related scientific discipline.
• 3–5 years of experience in Quality Assurance or Quality Control within the pharmaceutical industry.
• Strong understanding of cGMP, ICH guidelines, and other relevant pharmaceutical regulations.
• Experience with auditing, deviation management, change control, and CAPA systems.
• Excellent analytical, problem-solving, and organizational skills.
• Strong written and verbal communication skills.
• Ability to work independently and collaboratively in a team environment.
• Proficiency in using quality management software and standard office applications.
• Experience working within a Hybrid model is beneficial.
• Must be based in or willing to relocate to the vicinity of Randburg, Gauteng.

Responsibilities

• Develop, implement, and maintain the company's Quality Management System (QMS) in line with cGMP and other regulatory requirements.
• Conduct internal audits and participate in external audits (e.g., regulatory inspections, customer audits).
• Review and approve batch records, validation protocols, and other quality-related documents.
• Manage deviations, out-of-specification (OOS) results, and change controls.
• Participate in risk assessments and implement risk mitigation strategies.
• Develop and deliver quality assurance training programs to relevant personnel.
• Monitor quality metrics and prepare reports for senior management.
• Ensure all quality-related activities are documented accurately and maintained for regulatory compliance.
• Liaise with regulatory authorities and third-party inspectors as required.
• Contribute to the continuous improvement of quality processes and systems within the Randburg facility.

Skills

Auditing

cGMP knowledge

Problem solving

Communication

Documentation

Teamwork

Education

Bachelor's degree in Pharmacy, Chemistry, Biotechnology, or related discipline

Tools

Quality Management Software

MS Office

Job description

About the Role

Our client, a rapidly expanding pharmaceutical company, is seeking a diligent and experienced Pharmaceutical Quality Assurance Officer to join their team in Randburg, Gauteng. This role is critical in maintaining the integrity and compliance of our pharmaceutical products throughout their lifecycle. The QA Officer will be responsible for overseeing and implementing quality management systems, ensuring adherence to regulatory standards, and supporting continuous improvement initiatives. This position offers a unique opportunity to contribute to the quality and safety of medicines. The role is structured as a Hybrid position, combining essential on-site quality oversight with flexible remote data analysis and documentation review, promoting a modern and effective work approach.

Key Responsibilities

• Develop, implement, and maintain the company's Quality Management System (QMS) in line with cGMP and other relevant regulatory requirements.
• Conduct internal audits and participate in external audits (e.g., regulatory inspections, customer audits).
• Review and approve batch records, validation protocols, and other quality-related documents.
• Manage deviations, out-of-specification (OOS) results, and change controls.
• Participate in risk assessments and implement risk mitigation strategies.
• Develop and deliver quality assurance training programs to relevant personnel.
• Monitor quality metrics and prepare reports for senior management.
• Ensure all quality-related activities are documented accurately and maintained for regulatory compliance.
• Liaise with regulatory authorities and third-party inspectors as required.
• Contribute to the continuous improvement of quality processes and systems within the Randburg facility.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biotechnology, or a related scientific discipline.
• Minimum of 3-5 years of experience in Quality Assurance or Quality Control within the pharmaceutical industry.
• Strong understanding of cGMP, ICH guidelines, and other relevant pharmaceutical regulations.
• Experience with auditing, deviation management, change control, and CAPA systems.
• Excellent analytical, problem-solving, and organizational skills.
• Strong written and verbal communication skills.
• Ability to work independently and collaboratively in a team environment.
• Proficiency in using quality management software and standard office applications.
• Experience working within a Hybrid model is beneficial.
• Must be based in or willing to relocate to the vicinity of Randburg, Gauteng .

Benefits

• Our client offers a competitive salary of ZAR per annum , along with performance-based bonuses and a comprehensive benefits package including medical aid and a retirement fund.
• Employees benefit from professional development opportunities, access to modern quality assurance systems, and a supportive work culture.
• The Hybrid model enhances work-life balance.