Hybrid QA Specialist - Pharma Manufacturing

Placements24; Mtubatuba Local Municipality; Híbrido; ZAR 600.000 - 900.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health insurance

Retirement benefits

Professional development

Descripción de la vacante

Placements24 is seeking a meticulous Quality Assurance Specialist for a pharmaceutical manufacturing facility in Richards Bay, KwaZulu-Natal. The role focuses on implementing and maintaining QMS, conducting audits, and investigating deviations within a hybrid work model.

Ideal candidates have a Bachelor’s degree in a relevant science and at least 4 years in QA/QC, with strong GMP/regulatory knowledge and excellent documentation and communication skills.

Formación

• Bachelor's degree in Pharmacy, Chemistry, Biology or related scientific discipline.
• Minimum of 4 years of experience in Quality Assurance or Quality Control within the pharmaceutical industry.
• Strong understanding of GMP, regulatory requirements (FDA, SAHPRA), and quality control principles.
• Experience with QMS, CAPA systems, change control, and deviation management.
• Proficiency in conducting risk assessments and root cause analysis.
• Excellent documentation, communication, and interpersonal skills.
• Ability to work effectively both independently and as part of a team.
• Detail-oriented with strong problem-solving abilities.
• Experience with auditing and regulatory inspections is highly desirable.

Responsabilidades

• Develop, implement, and maintain quality management systems (QMS) in accordance with cGMP and other relevant standards.
• Conduct internal and external audits of manufacturing processes, facilities, and suppliers to ensure compliance.
• Review and approve batch records, validation protocols, and other quality-related documentation.
• Investigate deviations, out-of-specification (OOS) results, and customer complaints, identifying root causes and implementing corrective and preventive actions (CAPAs).
• Participate in regulatory inspections and ensure the site is prepared for audits.
• Develop and deliver quality training programs to manufacturing and other relevant personnel.
• Monitor key quality metrics and prepare reports for management review.
• Contribute to process improvement initiatives to enhance product quality and manufacturing efficiency.

Conocimientos

GMP knowledge

QMS & CAPA

Audit experience

Documentation

Risk assessment

Regulatory knowledge

Communication skills

Teamwork

Educación

Bachelor's degree in Pharmacy, Chemistry, Biology

Descripción del empleo

Placements24 is seeking a meticulous Quality Assurance Specialist for a pharmaceutical manufacturing facility in Richards Bay, KwaZulu-Natal. The role focuses on implementing and maintaining QMS, conducting audits, and investigating deviations within a hybrid work model.

Ideal candidates have a Bachelor’s degree in a relevant science and at least 4 years in QA/QC, with strong GMP/regulatory knowledge and excellent documentation and communication skills.