Senior Quality Assurance Specialist

Placements24; Kimberley; On-site; ZAR 600,000 - 900,000; Full time

Benefits offered by this job

Health insurance

Pension fund contributions

Paid time off

Job summary

Placements24 seeks a Senior Quality Assurance Specialist for their Kimberley, Northern Cape facility. The role focuses on GMP compliance, QA leadership, and collaboration across production, QC, and regulatory affairs.

The ideal candidate has 5+ years of QA experience in pharma, strong documentation discipline, and the ability to drive continuous improvement in a busy manufacturing environment. This is an office-based position with clear advancement opportunities.

Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific discipline.
• Minimum of 5 years of experience in Quality Assurance within the pharmaceutical industry.
• Thorough understanding of GMP principles and regulatory requirements (SAHPRA, FDA, EMA).
• Experience with QMS elements such as audits, deviations, CAPA, change control, and batch record review.
• Strong analytical and problem-solving skills.
• Excellent attention to detail and organizational abilities.
• Effective communication and interpersonal skills.
• Ability to work independently and as part of a team.

Responsibilities

• Develop, implement, and maintain quality management systems (QMS) in accordance with GMP and other regulatory requirements.
• Conduct internal audits of manufacturing processes, facilities, and documentation to ensure compliance.
• Review and approve batch records, validation protocols, and deviations.
• Manage and investigate deviations, OOS results, and CAPAs.
• Participate in external audits and regulatory inspections.
• Provide QA support for manufacturing operations, including batch release.
• Develop and deliver quality training programs to relevant personnel.
• Manage change control processes and ensure proper documentation.
• Monitor quality metrics and identify areas for continuous improvement.
• Collaborate with various departments, including production, quality control, and regulatory affairs.
• Stay up-to-date with evolving GMP regulations and industry best practices.
• Maintain accurate and organized quality records.

Skills

Analytical skills

Problem solving

Communication

Teamwork

Independent work

Education

Bachelor's degree in Pharmacy/ Chemistry/ Biology

Tools

Microsoft Office Suite

QMS software

Job description

About the Role

Our client, a highly reputable pharmaceutical manufacturer, is seeking a diligent and experienced Senior Quality Assurance Specialist to join their team in Kimberley, Northern Cape. This role is essential for upholding the highest standards of quality and compliance across all manufacturing and operational processes. You will be instrumental in ensuring adherence to Good Manufacturing Practices (GMP) and other relevant regulatory standards. This is a permanent, office-based position where your expertise will directly contribute to the integrity and safety of pharmaceutical products. The successful candidate will be a key player in maintaining our client's commitment to quality excellence from their Kimberley facility.

Key Responsibilities

• Develop, implement, and maintain quality management systems (QMS) in accordance with GMP and other regulatory requirements.


• Conduct internal audits of manufacturing processes, facilities, and documentation to ensure compliance.


• Review and approve batch records, validation protocols, and deviations.


• Manage and investigate deviations, out-of-specification (OOS) results, and CAPAs (Corrective and Preventive Actions).


• Participate in external audits and regulatory inspections.


• Provide QA support for manufacturing operations, including batch release.


• Develop and deliver quality training programs to relevant personnel.


• Manage change control processes and ensure proper documentation.


• Monitor quality metrics and identify areas for continuous improvement.


• Collaborate with various departments, including production, quality control, and regulatory affairs.


• Stay up-to-date with evolving GMP regulations and industry best practices.


• Maintain accurate and organized quality records.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific discipline.


• Minimum of 5 years of experience in Quality Assurance within the pharmaceutical industry.


• Thorough understanding of GMP principles and regulatory requirements (e.g., SAHPRA, FDA, EMA).


• Experience with quality management system elements such as audits, deviations, CAPA, change control, and batch record review.


• Strong analytical and problem-solving skills.


• Excellent attention to detail and organizational abilities.


• Effective communication and interpersonal skills.


• Ability to work independently and as part of a team.


• Proficiency in Microsoft Office Suite and experience with quality management software.


• Experience in sterile manufacturing or API production is a plus.

Benefits

• A competitive annual salary up to R .


• Comprehensive health, dental, and vision insurance.


• Generous paid time off and company holidays.


• Opportunities for professional development and further training.


• Pension fund contributions.


• Performance-based incentives.


• A stable and supportive work environment in Kimberley.


• Potential for career advancement within the organization.