Senior Quality Assurance Specialist - Pharma

Placements24; Durban; Hybrid; ZAR 700,000 - 1,000,000; Full time

Benefits offered by this job

Competitive salary

Health, dental, and vision insurance

Generous leave & holidays

Career growth in QA

Collaborative QA environment

Job summary

Placements24 in Durban is seeking a Senior Quality Assurance Specialist to strengthen our quality management system within pharmaceutical operations. You will ensure compliance with GMP and SAHPRA guidelines across the product lifecycle.

You will lead audits, review batch records, manage deviations and CAPA, and mentor staff on quality systems while driving continuous improvement and preparing for regulatory inspections.

Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Life Sciences or related field.
• Minimum 5 years of QA experience in the pharmaceutical industry.
• Strong knowledge of GMP and regulatory requirements.
• Experience with quality risk management, validation and change control.
• Excellent documentation, investigation and problem-solving skills.
• Strong communication and cross-department collaboration in Durban.

Responsibilities

• Develop, implement, and maintain quality assurance programs and procedures compliant with GMP and relevant regulatory guidelines (e.g., SAHPRA).
• Conduct internal audits, supplier audits, and participate in regulatory inspections to ensure compliance.
• Review and approve batch records, validation protocols and other critical quality documentation.
• Manage deviations, investigations, and CAPA (Corrective and Preventive Actions) processes to ensure timely and effective resolution.
• Provide training and guidance to personnel on quality systems and regulatory compliance matters.
• Contribute to the continuous improvement of quality processes and systems across the organization.

Skills

GMP knowledge

Quality risk management

Validation

Change control

Documentation & investigations

Problem-solving

Communication & collaboration

Education

Bachelor's degree in Pharmacy, Chemistry, Life Sciences or related field

Job description

About the Role

Our client is seeking a detail-oriented and experienced Senior Quality Assurance Specialist to enhance their quality management system within the pharmaceutical operations in Durban. This critical role ensures adherence to stringent regulatory standards and internal quality policies throughout the product lifecycle. You will be instrumental in maintaining compliance, driving continuous improvement initiatives, and supporting regulatory inspections and audits. The ideal candidate possesses a strong understanding of GMP, a keen eye for detail, and the ability to effectively manage quality-related activities in a fast-paced pharmaceutical manufacturing environment.

Key Responsibilities

• Develop, implement, and maintain quality assurance programs and procedures compliant with GMP and relevant regulatory guidelines (e.g., SAHPRA).
• Conduct internal audits, supplier audits, and participate in regulatory inspections to ensure compliance.
• Review and approve batch records, validation protocols and other critical quality documentation.
• Manage deviations, investigations, and CAPA (Corrective and Preventive Actions) processes to ensure timely and effective resolution.
• Provide training and guidance to personnel on quality systems and regulatory compliance matters.
• Contribute to the continuous improvement of quality processes and systems across the organization.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or a related field.
• A minimum of 5 years of experience in Quality Assurance within the pharmaceutical industry.
• In-depth knowledge of Good Manufacturing Practices (GMP) and pharmaceutical regulatory requirements.
• Experience with quality risk management, validation, and change control processes.
• Excellent documentation, investigation, and problem-solving skills.
• Strong communication and interpersonal skills, with the ability to collaborate effectively across departments in Durban.

Benefits

• Competitive annual salary and potential for performance-based incentives.
• Comprehensive health, dental, and vision insurance plans.
• Generous annual leave and paid holidays.
• Opportunities for professional growth and development within the QA function.
• A collaborative work environment focused on ensuring the highest quality standards in pharmaceutical production.