Pharma QA Specialist - QMS, Audits & CAPAs

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

Benefits offered by this job

Competitive salary

Medical aid and provident fund

Performance-based bonuses

Professional growth opportunities

Modern lab equipment access

Collaborative work environment

Paid annual leave and sick leave

Leadership opportunities in Quality

Job summary

Placements24 seeks a thorough Quality Assurance Specialist for our George, Western Cape facility. The role ensures pharmaceutical product quality, regulatory compliance and robust QMS maintenance on-site, supporting deviations, CAPAs and change control with cross-functional teams.

The successful candidate will have a Bachelor's in a scientific field and at least 4 years in QA within pharma or biotech, with strong analytical skills and meticulous attention to detail.

Qualifications

• Develop, implement and maintain the Quality Management System (QMS) in line with cGMP and regulatory guidelines.
• Conduct internal audits and support external regulatory inspections.
• Review batch records, validation protocols and reports for adherence to quality standards.
• Investigate deviations, OOS and customer complaints; implement CAPAs.
• Oversee change control processes and assess impact on product quality.
• Manage vendor qualification and auditing for raw materials and services.
• Deliver QA training to relevant personnel.
• Monitor quality data to identify trends and opportunities for process improvement.

Responsibilities

• Develop, implement and maintain the Quality Management System (QMS) in accordance with cGMP and other relevant regulatory guidelines.
• Conduct internal audits and participate in external regulatory inspections, ensuring preparedness and compliance.
• Review and approve batch records, validation protocols, and reports to ensure adherence to established quality standards.
• Investigate deviations, out-of-specification (OOS) results, and customer complaints, implementing corrective and preventive actions (CAPAs) as necessary.
• Manage change control processes, assessing the impact of changes on product quality and regulatory compliance.
• Oversee vendor qualification and auditing processes to ensure the quality of raw materials and services.
• Develop and deliver quality assurance training programs to relevant personnel within the organization.
• Monitor and analyze quality data to identify trends and opportunities for process improvement.
• Ensure all activities comply with relevant health, safety, and environmental regulations.

Skills

Audits

CAPA implementation

Change control

Regulatory compliance

Analytical skills

Attention to detail

Time management

Cross-functional collaboration

Education

Bachelor's degree in Pharmacy, Chemistry, Microbiology, or related field

Tools

QMS software

Job description

Placements24 seeks a thorough Quality Assurance Specialist for our George, Western Cape facility. The role ensures pharmaceutical product quality, regulatory compliance and robust QMS maintenance on-site, supporting deviations, CAPAs and change control with cross-functional teams.

The successful candidate will have a Bachelor's in a scientific field and at least 4 years in QA within pharma or biotech, with strong analytical skills and meticulous attention to detail.