Quality Assurance Specialist - Pharmaceutical Manufacturing

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

About the Role

Our client is seeking a diligent and experienced Quality Assurance Specialist to join their state-of-the-art pharmaceutical manufacturing facility in George, Western Cape . This role is essential in upholding the highest standards of product quality, regulatory compliance, and operational excellence. The successful candidate will be instrumental in developing, implementing, and maintaining robust quality systems that ensure all manufactured pharmaceuticals meet stringent safety and efficacy requirements. This position offers a fantastic opportunity for a detail-oriented professional to contribute significantly to a company dedicated to producing life-saving medications. Working on-site in George allows for direct engagement with manufacturing processes and a hands-on approach to quality control, fostering a deeply integrated understanding of the product lifecycle.

Key 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.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Microbiology, or a related scientific field.
• Minimum of 4 years of experience in a Quality Assurance role within the pharmaceutical or biotechnology industry.
• Solid understanding of current Good Manufacturing Practices (cGMP), ISO standards, and other relevant regulatory requirements.
• Demonstrated experience in conducting and managing internal and external audits.
• Proficiency in deviation management, CAPA implementation, and change control procedures.
• Strong analytical and problem-solving skills with a high degree of accuracy and attention to detail.
• Excellent organizational and time management skills, with the ability to manage multiple tasks simultaneously.
• Effective communication and interpersonal skills, with the ability to collaborate with cross-functional teams.
• Familiarity with validation principles for manufacturing processes, equipment, and analytical methods.

Benefits

• Competitive salary commensurate with experience.
• Comprehensive medical aid and provident fund.
• Performance-based bonuses and incentives.
• Opportunities for professional growth and advanced training in quality management.
• Access to modern laboratory equipment and manufacturing technologies.
• A supportive and collaborative work environment focused on innovation.
• Paid annual leave and sick leave benefits.
• Potential for leadership opportunities within the Quality department.