GMP QA Specialist – Pharmaceutical Manufacturing (Mossel Bay)

Placements24; Mossel Bay; Presencial; ZAR 420.000 - 720.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Competitive salary and benefits

Medical aid plan

Retirement fund contributions

Performance-based bonuses

Generous annual leave

Professional development opportunities

Descripción de la vacante

Placements24 is seeking a meticulous Quality Assurance Specialist for a pharmaceutical manufacturing facility in Mossel Bay, Western Cape. The role ensures GMP-compliant processes and products, maintains regulatory readiness, and drives continuous improvement within a hands-on environment.

The ideal candidate has a Bachelor's degree in a scientific field and at least 4 years' QA/QC experience, with proven skills in batch-review, internal audits, CAPA, validation, and change control.

Formación

• Bachelor's degree in Pharmacy, Chemistry, Biology, or related scientific discipline.
• Minimum 4 years of QA/QC experience in pharmaceutical or medical device industry.
• Solid GMP, ICH guidelines and pharma quality systems knowledge.
• Experience reviewing batch records, internal audits, and CAPA management.
• Familiarity with validation principles and change control processes.
• Strong analytical and problem-solving skills with meticulous attention to detail.
• Excellent written and verbal communication skills.
• Ability to work independently and collaboratively within a team.
• Proficiency with MS Office and quality management software desirable.

Responsabilidades

• Review and approve batch manufacturing records, ensuring adherence to procedures.
• Conduct internal audits of manufacturing processes, quality systems, and documentation.
• Investigate deviations, OOS results, and customer complaints, implementing CAPA.
• Participate in qualification and validation of equipment, processes, and analytical methods.
• Develop, revise, and implement SOPs and other quality-related documents.
• Monitor key quality indicators and participate in quality management review meetings.
• Manage change control processes, assessing impact on product quality and regulatory compliance.
• Support external regulatory inspections and audits with documentation and explanations.
• Train manufacturing personnel on GMP principles and quality system requirements.
• Release finished products after thorough review of all documentation and compliance checks.

Conocimientos

GMP knowledge

CAPA experience

Internal audits

Batch record review

Quality systems

Analytical skills

Problem-solving

Documentation skills

Cross-functional collaboration

MS Office proficiency

Educación

Bachelor's degree in Pharmacy

Bachelor's degree in Chemistry

Bachelor's degree in Biology

Herramientas

Quality management software

MS Office

Descripción del empleo

Placements24 is seeking a meticulous Quality Assurance Specialist for a pharmaceutical manufacturing facility in Mossel Bay, Western Cape. The role ensures GMP-compliant processes and products, maintains regulatory readiness, and drives continuous improvement within a hands-on environment.

The ideal candidate has a Bachelor's degree in a scientific field and at least 4 years' QA/QC experience, with proven skills in batch-review, internal audits, CAPA, validation, and change control.