Senior Pharmaceutical Quality Assurance Specialist

Placements24; Sandton; Hybrid; ZAR 900,000 - 1,300,000; Full time

Benefits offered by this job

Health and wellness benefits

Retirement savings plan

Professional development opportunities

Job summary

Placements24 seeks a Senior Pharmaceutical Quality Assurance Specialist in Sandton, Gauteng. The role focuses on sustaining and improving the Quality Management System (QMS) and ensuring compliance with global regulatory standards.

You will lead internal audits, support inspections, and drive continuous improvement across the product lifecycle. The candidate will possess deep knowledge of pharmaceutical quality systems, cGMP/ICH guidelines, and strong analytical and communication skills.

Qualifications

• Bachelor’s degree in Pharmacy, Chemistry, Biology or related field.
• Master’s degree or QA certification preferred.
• Minimum 6 years in pharmaceutical Quality Assurance.
• Strong knowledge of cGMP, ICH and global regs.
• Experience building/maintaining QMS and conducting audits.
• Validation knowledge (process, cleaning, equipment).
• Excellent communication and leadership skills.
• Proficiency with QA software; Sandton area advantageous.

Responsibilities

• Develop, implement, and maintain the QMS in line with cGMP and international standards.
• Conduct internal audits of manufacturing processes and documentation.
• Support regulatory inspections by authorities (SAHPRA, FDA, EMA).
• Review and approve validation docs, batch records, and deviations.
• Manage CAPAs, deviations, and change controls.
• Oversee supplier qualification and audits.
• Provide QA oversight across product lifecycle and training.

Skills

cGMP knowledge

Regulatory audits

Quality management

Analytical thinking

Education

Bachelor's degree in Pharmacy

Master's degree or QA cert (preferred)

Tools

QA software

Job description

About the Role

Our client, a respected pharmaceutical company, is seeking a highly experienced Senior Pharmaceutical Quality Assurance Specialist to join their team in Sandton, Gauteng. This role is essential in maintaining and improving the company's quality management system (QMS) and ensuring compliance with global regulatory standards. You will be responsible for developing, implementing, and overseeing quality assurance processes, conducting internal audits, and supporting regulatory inspections. The ideal candidate possesses a deep understanding of pharmaceutical quality systems, regulatory requirements, and excellent analytical and communication skills. This is a key position within a company committed to excellence in pharmaceutical manufacturing and development, located in Sandton, Gauteng.

Key Responsibilities

• Develop, implement, and maintain the company's Quality Management System (QMS) in accordance with cGMP and relevant international standards.
• Conduct internal audits and inspections of manufacturing processes, facilities, and documentation to ensure compliance.
• Support external regulatory audits and inspections by health authorities (e.g., SAHPRA, FDA, EMA).
• Review and approve validation protocols and reports, batch records, and deviations.
• Manage and investigate deviations, CAPAs (Corrective and Preventive Actions), and change controls.
• Participate in supplier qualification and auditing processes.
• Provide QA oversight for various stages of the product lifecycle, from development to post-market surveillance.
• Develop and deliver quality assurance training programs for company personnel.
• Stay current with evolving regulatory requirements and industry best practices in quality assurance.
• Collaborate with cross-functional teams to promote a culture of quality throughout the organization.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific field.
• A Master's degree or specialized QA certification is preferred.
• Minimum of 6 years of progressive experience in pharmaceutical Quality Assurance.
• In-depth knowledge of cGMP, ICH guidelines, and global regulatory requirements.
• Proven experience in developing and managing QMS, conducting audits, and handling regulatory inspections.
• Strong understanding of validation processes (process, cleaning, equipment).
• Excellent analytical, problem-solving, and critical thinking skills.
• Exceptional written and verbal communication skills, with the ability to influence and lead.
• Proficiency in quality management software and tools.
• Experience in the Sandton, Gauteng area is advantageous.
• Ability to work effectively both independently and as part of a collaborative team.

Benefits

Our client offers a competitive salary, comprehensive health and wellness benefits, and a retirement savings plan. Opportunities for continuous professional development, including advanced training and participation in industry conferences, are provided. The company fosters a culture of innovation and collaboration. This role offers a significant career opportunity within the pharmaceutical quality assurance field in Sandton, Gauteng.