Senior Pharma QA & Compliance Lead

Placements24; Kempton Park; Híbrido; ZAR 900.000 - 1.200.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Competitive benefits package

Hybrid work model

Professional development opportunities

Descripción de la vacante

Placements24 is seeking a Senior Pharmaceutical Quality Assurance Specialist in Tembisa, Gauteng. The role combines on-site QA oversight with remote documentation work, ensuring GMP compliance, batch record integrity, and CAPA implementation.

You will conduct internal audits, support external inspections, and drive continuous improvement across quality systems and SOPs, with collaboration across cross-functional teams.

Formación

• Bachelor's degree in Pharmacy, Chemistry, Biotechnology, or related field.
• Minimum of 5 years in pharmaceutical Quality Assurance or Quality Control.
• Thorough understanding of GMP, ICH guidelines, and other regulatory requirements.
• Proven experience with batch record review, deviation management, CAPA, and change control systems.
• Experience with internal and external audits is essential.
• Strong analytical, problem-solving, and decision-making skills.
• Excellent documentation and technical writing abilities.

Responsabilidades

• Review and approve batch production records, analytical data, and release documentation to ensure compliance with specifications and regulatory requirements.
• Manage and investigate deviations, OOS results, and customer complaints, implementing CAPAs.
• Oversee the change control process, assess impact on product quality and regulatory compliance.
• Conduct internal audits and participate in external regulatory inspections, ensuring readiness and addressing findings.
• Develop, review, and implement Quality Assurance procedures and SOPs.
• Monitor manufacturing processes for GMP compliance.
• Participate in vendor qualification and auditing processes.
• Train personnel on quality system requirements and GMP principles.
• Maintain quality metrics and generate reports for management review.
• Support product lifecycle management and continuous improvement initiatives.

Conocimientos

QA expertise

GMP/ICH knowledge

Batch record review

Deviation management

CAPA

Change control

Audits (internal/external)

Data analysis

Technical writing

Quality software

Cross-functional skills

Communication skills

Educación

Bachelor's degree in Pharmacy/Science

Herramientas

Quality management software

MS Office

Descripción del empleo

Placements24 is seeking a Senior Pharmaceutical Quality Assurance Specialist in Tembisa, Gauteng. The role combines on-site QA oversight with remote documentation work, ensuring GMP compliance, batch record integrity, and CAPA implementation.

You will conduct internal audits, support external inspections, and drive continuous improvement across quality systems and SOPs, with collaboration across cross-functional teams.