Quality Assurance Specialist (Pharma)

Placements24; Pretoria; Híbrido; ZAR 600.000 - 900.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Private health insurance

retirement fund benefits

Generous annual leave

Remote work flexibility

Continuous professional development

On-site requirements when needed

Descripción de la vacante

Placements24 in Pretoria, Gauteng, is seeking a proactive Quality Assurance Specialist to uphold GMP standards across manufacturing and distribution. You will lead internal audits, review batch records, and drive CAPA actions, ensuring product integrity from development to release.

This role blends remote work flexibility with essential on-site presence for audits, trainings, and critical documentation reviews.

Formación

• Bachelor's degree in Pharmaceutical Sciences, Chemistry, Biology, or a related field.
• Minimum of 4 years of QA/QC experience in the pharmaceutical industry.
• Strong knowledge of GMP, ICH guidelines and regulatory requirements.
• Experience auditing, documentation review and deviation management.
• Excellent analytical, problem-solving and organizational skills.
• Proficient in MS Office and QMS software.
• Strong written and verbal English communication; ability to work remotely.

Responsabilidades

• Implement and maintain the QMS in line with GMP and regulatory standards.
• Conduct internal audits and participate in external audits by authorities and customers.
• Review and approve batch records, validation protocols and key quality documents.
• Investigate deviations and OOS results, execute CAPAs and preventive actions.
• Develop and monitor quality control procedures and standards.
• Support process validation and equipment qualification activities.
• Provide QA support for product development, manufacturing and release.
• Train personnel on quality systems, GMP and related topics.
• Monitor KPIs and report on QMS performance.
• Keep up to date with industry best practices and regulatory changes.

Conocimientos

Auditing

Documentation review

CAPA implementation

Regulatory compliance

Analytical skills

GMP knowledge

Educación

Bachelor's degree in Pharmaceutical Sciences, Chemistry, Biology, or a related field

Herramientas

MS Office Suite

QMS software

Descripción del empleo

About the Role

Our client, a distinguished name in the pharmaceutical sector, is actively seeking a proactive and diligent Quality Assurance Specialist to join their esteemed team in Pretoria, Gauteng. This role is fundamental to upholding the highest standards of quality across all operations, ensuring compliance with Good Manufacturing Practices (GMP) and other relevant regulatory requirements. You will be involved in a wide range of QA activities, including internal audits, documentation review, process improvement initiatives, and ensuring the integrity of pharmaceutical products. This position is ideal for a detail-oriented professional who is passionate about quality control and eager to contribute to a company committed to producing safe and effective medicines. As a fully remote position, it offers flexibility while maintaining a critical on-site presence for essential tasks as needed.

Key Responsibilities

• Implement and maintain the Quality Management System (QMS) in accordance with GMP and regulatory standards.
• Conduct internal audits and participate in external audits by regulatory authorities and customers.
• Review and approve batch records, validation protocols, and other critical quality documentation.
• Investigate deviations, out-of-specification (OOS) results, and customer complaints, and implement corrective and preventive actions (CAPAs).
• Develop, implement, and monitor quality control procedures and standards.
• Participate in process validation and equipment qualification activities.
• Provide QA support for product development, manufacturing, and release activities.
• Train personnel on quality systems, GMP, and related topics.
• Monitor key quality indicators and report on the overall performance of the QMS.
• Stay current with industry best practices and regulatory changes impacting pharmaceutical quality assurance.

Requirements

• Bachelor's degree in Pharmaceutical Sciences, Chemistry, Biology, or a related field.
• Minimum of 4 years of experience in Quality Assurance or Quality Control within the pharmaceutical industry.
• Strong knowledge of GMP, ICH guidelines, and other relevant regulatory requirements.
• Proven experience in auditing, documentation review, and deviation management.
• Excellent analytical, problem-solving, and organizational skills.
• Proficiency in MS Office Suite and experience with Quality Management System (QMS) software.
• Strong written and verbal communication skills in English.
• Ability to work independently and manage tasks effectively in a remote setting.
• Familiarity with validation principles for processes and equipment.
• Resides within proximity to Pretoria, Gauteng for occasional site visits or is open to travel as needed.

Benefits

• Competitive salary and performance incentives.
• Comprehensive private health insurance coverage.
• Retirement fund benefits.
• Generous annual leave and public holiday allowance.
• Opportunities for continuous professional development and certifications.
• Remote work flexibility with essential on-site requirements.
• Exposure to diverse pharmaceutical products and manufacturing processes.
• A culture that prioritizes quality, safety, and innovation.