Pharmaceutical Quality Assurance Specialist - GMP Compliance

Placements24; Centurion; On-site; ZAR 500,000 - 700,000; Full time

Benefits offered by this job

Medical aid

Provident fund

Annual performance bonuses

Professional development opportunities

On-site Centurion location

Job summary

Placements24 seeks a meticulous Pharmaceutical Quality Assurance Specialist in Centurion, Gauteng. The role ensures GMP-aligned QA across manufacturing and distribution, engaging with production, QA, and regulatory affairs to sustain a strong quality culture.

You will conduct internal audits, participate in SAHPRA inspections, review batch records, CAPAs, and change controls. On-site involvement, with a focus on process improvement and regulatory compliance, drives patient safety and product

Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Biotechnology or related scientific discipline.
• Minimum of 3 years in pharmaceutical Quality Assurance or Quality Control.
• Strong understanding of GMP guidelines and SAHPRA relevance to pharmaceutical manufacturing.
• Experience with internal audits and regulatory inspections.
• Proficiency in investigating deviations, OOS results, and CAPA implementation.
• Familiarity with validation processes (process, cleaning, analytical method validation).
• Strong analytical and problem-solving skills with excellent attention to detail.
• Effective communication and interpersonal skills, with the ability to collaborate across departments.
• Proficiency in quality management software and standard office applications.
• Knowledge of SAHPRA regulatory requirements.

Responsibilities

• Develop, implement, and maintain Quality Assurance systems and procedures in accordance with GMP.
• Conduct internal audits of manufacturing processes, documentation, and facilities to ensure compliance.
• Participate in regulatory inspections from health authorities (e.g., SAHPRA) and prepare responses to audit findings.
• Review and approve batch records, validation protocols, and other critical quality documents.
• Investigate deviations, out-of-specification (OOS) results, and customer complaints, implementing CAPAs.
• Manage change control processes to ensure changes to processes, materials, or equipment are evaluated and documented.
• Perform vendor qualification audits and manage supplier quality agreements.
• Contribute to the training of personnel on GMP principles and quality procedures.
• Monitor key quality indicators (KQIs) and report on the status of the quality system to management.
• Ensure proper calibration and maintenance of laboratory and manufacturing equipment.

Skills

Analytical thinking

Problem-solving

Communication skills

Interpersonal skills

Quality management software

Education

Bachelor's degree in Pharmacy

Bachelor's degree in Chemistry

Tools

QA software

Office software

Job description

About the Role

Our client is seeking a meticulous and dedicated Pharmaceutical Quality Assurance Specialist to join their operations in Centurion, Gauteng . This role is critical in ensuring that all pharmaceutical products manufactured and distributed by the company meet the highest standards of quality, safety, and efficacy. You will be responsible for upholding Good Manufacturing Practice (GMP) regulations, conducting internal audits, and participating in external regulatory inspections. This is a hands-on, on-site position that requires a strong understanding of pharmaceutical quality systems and regulatory compliance. The ideal candidate will possess a keen eye for detail, excellent analytical skills, and a proactive approach to identifying and mitigating potential quality risks. You will work closely with production, quality control, and regulatory affairs departments to maintain a robust quality culture throughout the organization. This role offers the opportunity to contribute significantly to the company's commitment to quality and patient well-being.

Key Responsibilities

• Develop, implement, and maintain Quality Assurance systems and procedures in accordance with GMP.
• Conduct internal audits of manufacturing processes, documentation, and facilities to ensure compliance.
• Participate in regulatory inspections from health authorities (e.g., SAHPRA) and prepare responses to audit findings.
• Review and approve batch records, validation protocols, and other critical quality documents.
• Investigate deviations, out-of-specification (OOS) results, and customer complaints, implementing corrective and preventive actions (CAPAs).
• Manage change control processes to ensure that any changes to processes, materials, or equipment are properly evaluated and documented.
• Perform vendor qualification audits and manage supplier quality agreements.
• Contribute to the training of personnel on GMP principles and quality procedures.
• Monitor key quality indicators (KQIs) and report on the status of the quality system to management.
• Ensure the proper calibration and maintenance of laboratory and manufacturing equipment.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biotechnology, or a related scientific discipline.
• Minimum of 3 years of experience in pharmaceutical Quality Assurance or Quality Control.
• Thorough understanding and practical experience with GMP guidelines and regulations relevant to pharmaceutical manufacturing.
• Experience in conducting internal audits and participating in regulatory inspections.
• Proficiency in investigating deviations, OOS results, and CAPA implementation.
• Familiarity with validation processes (process, cleaning, analytical method validation).
• Strong analytical and problem-solving skills with excellent attention to detail.
• Effective communication and interpersonal skills, with the ability to collaborate across departments.
• Proficiency in using quality management software and standard office applications.
• Knowledge of regulatory requirements in the South African pharmaceutical market (SAHPRA).

Benefits

• Our client provides a competitive salary and a comprehensive benefits package, including medical aid, a provident fund, and annual performance bonuses.
• Employees have access to ongoing professional development opportunities and training programs to enhance their skills in pharmaceutical quality.
• The role is based on-site in Centurion, Gauteng , offering a stable and structured work environment.
• You will be part of a dedicated quality team focused on upholding the highest standards in pharmaceutical manufacturing.
• The position presents an excellent opportunity for career growth within a reputable organization committed to producing safe and effective medicines.