Lead Quality Assurance Engineer

Placements24; Durban; On-site; ZAR 900,000 - 1,500,000; Full time

Benefits offered by this job

Competitive salary package

Job summary

Placements24 seeks a Lead Quality Assurance Engineer for a pharmaceutical manufacturing facility in Durban. The role leads the QA function, develops the QMS, and ensures products meet stringent regulatory standards and patient safety requirements.

The ideal candidate has a Bachelor's degree in a scientific field and 8+ years of QA leadership experience within pharma or medical devices, with strong GMP/ICH knowledge and excellent communication skills.

Qualifications

• Bachelor's degree in a scientific field (Pharmacy, Chemistry, Engineering) is required.
• Minimum 8 years of QA experience in pharmaceutical/medical device industries.

Responsibilities

• Develop, implement, and maintain the Quality Management System (QMS) in line with GMP/ICH and other standards.
• Lead and mentor a team of QA professionals and manage QA activities.
• Oversee quality control processes including batch record review, deviation management, and change control.
• Conduct internal audits and support regulatory inspections and customer audits.
• Investigate product quality complaints and CAPAs to drive continuous improvement.
• Collaborate with manufacturing, R&D, and other departments to ensure product quality throughout lifecycle.

Skills

Strong analytical

Problem solving

Decision making

Excellent communication

Interpersonal skills

Education

Bachelor's degree in Pharmacy, Chemistry, Engineering

Job description

About the Role

Our client is seeking a highly skilled and motivated Lead Quality Assurance Engineer to spearhead quality initiatives within their pharmaceutical manufacturing facility in Durban . This leadership role is critical for ensuring that all products meet stringent quality standards and regulatory requirements. You will be responsible for developing, implementing, and managing the overall Quality Management System (QMS), leading a team of QA professionals, and driving continuous improvement efforts across all manufacturing and laboratory operations. This is an excellent opportunity to make a significant impact on product quality and patient safety in a challenging and rewarding environment.

Key Responsibilities

• Develop, implement, and maintain the site's Quality Management System (QMS) in compliance with pharmaceutical regulations (e.g., GMP, ISO).
• Lead and mentor a team of Quality Assurance professionals, providing guidance and performance management.
• Oversee quality control processes, including batch record review, deviation management, and change control.
• Conduct internal audits and support external regulatory inspections and customer audits.
• Investigate product quality complaints and non-conformances, implementing corrective and preventive actions (CAPAs).
• Collaborate with manufacturing, R&D, and other departments to ensure product quality throughout the lifecycle.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Engineering, or a related scientific field.
• Minimum of 8 years of experience in Quality Assurance within the pharmaceutical or medical device industry.
• Proven experience in leading QA teams and managing a QMS.
• Thorough understanding of GMP, ICH guidelines, and other relevant regulatory standards.
• Strong analytical, problem-solving, and decision-making skills.
• Excellent communication and interpersonal skills, with the ability to influence cross-functional teams.

Benefits

• Competitive salary package with annual bonus potential.
• Comprehensive medical aid and retirement fund contributions.
• Generous annual leave and paid sick leave.
• Opportunities for advanced training and career progression within the pharmaceutical sector.
• Dynamic work environment focused on quality and compliance in Durban .