Senior Quality Control Analyst - API

Placements24; Rustenburg; On-site; ZAR 480,000 - 720,000; Full time

Benefits offered by this job

Medical aid

Retirement fund

Professional growth

Job summary

Placements24 in Rustenburg, South Africa, is seeking a meticulous Senior Quality Control Analyst to lead analytical testing for APIs and finished products. The role emphasizes HPLC/GC proficiency, GMP compliance, and data integrity within a fast-growing pharmaceutical environment.

You will review data, troubleshoot methods, and contribute to method validation and transfer activities while mentoring junior analysts in a modern GMP facility in North West Province.

Qualifications

• Bachelor's or Master's degree in Chemistry, Analytical Chemistry, Pharmacy, or a related scientific field.
• Minimum of 4 years of relevant experience in a pharmaceutical Quality Control laboratory setting.
• Proficiency in a wide array of analytical techniques, with a strong emphasis on HPLC and GC.
• Thorough understanding of GMP principles and their application in a QC environment.
• Experience with method validation and transfer is highly desirable.
• Excellent attention to detail and accuracy in data recording and analysis.
• Strong problem-solving abilities and the capacity to work independently and as part of a team.
• Good written and verbal communication skills.

Responsibilities

• Perform analytical testing on raw materials, in-process samples, and finished products using HPLC, GC, UV-Vis, KF, and dissolution.
• Review and interpret analytical data, ensuring compliance with established specifications and procedures.
• Troubleshoot analytical methods and laboratory instrumentation, identifying root causes and implementing corrective actions.
• Participate in method validation, transfer, and verification activities for new and existing analytical methods.
• Maintain laboratory equipment and ensure its calibration and qualification.
• Prepare and review analytical test reports, SOPs, and other quality documentation.
• Ensure GMP compliance and regulatory guidelines are followed.
• Assist in training and mentoring junior QC analysts.

Skills

HPLC

GC

Dissolution

UV-Vis

KF

Troubleshooting

Education

Bachelor's or Master's in Chemistry/Analytical Chemistry/Pharmacy

Job description

About the Role

Our client, a rapidly expanding pharmaceutical manufacturing company, is seeking a meticulous and experienced Senior Quality Control Analyst to join their team in Rustenburg, North West . This role is essential for ensuring the quality and compliance of Active Pharmaceutical Ingredients (APIs) and finished products. The Senior QC Analyst will perform a wide range of analytical tests, troubleshoot laboratory issues, and contribute to method validation and transfer activities. This is a fantastic opportunity for a dedicated scientist to advance their career within a company committed to the highest standards of pharmaceutical quality. You will play a critical role in upholding product integrity and regulatory adherence, ensuring that all manufactured materials meet stringent global standards before they reach patients. The position demands a rigorous scientific approach and a deep understanding of analytical chemistry principles within a GMP environment.

Key Responsibilities

• Perform analytical testing on raw materials, in-process samples, and finished products using various techniques such as HPLC, GC, UV-Vis, KF, and dissolution.
• Review and interpret analytical data, ensuring compliance with established specifications and procedures.
• Troubleshoot analytical methods and laboratory instrumentation, identifying root causes and implementing corrective actions.
• Participate in method validation, transfer, and verification activities for new and existing analytical methods.
• Maintain laboratory equipment and ensure its calibration and qualification.
• Prepare and review analytical test reports, standard operating procedures (SOPs), and other quality documentation.
• Ensure all activities are conducted in compliance with Good Manufacturing Practices (GMP) and relevant regulatory guidelines.
• Assist in training and mentoring junior QC analysts.

Requirements

• Bachelor's or Master's degree in Chemistry, Analytical Chemistry, Pharmacy, or a related scientific field.
• Minimum of 4 years of relevant experience in a pharmaceutical Quality Control laboratory setting.
• Proficiency in a wide array of analytical techniques, with a strong emphasis on HPLC and GC.
• Thorough understanding of GMP principles and their application in a QC environment.
• Experience with method validation and transfer is highly desirable.
• Excellent attention to detail and accuracy in data recording and analysis.
• Strong problem-solving abilities and the capacity to work independently and as part of a team.
• Good written and verbal communication skills.

Benefits

• This position offers a competitive salary, comprehensive benefits package including medical aid and retirement fund contributions, and opportunities for professional growth and development within a reputable pharmaceutical company.
• You will be working in a modern facility in Rustenburg, North West , contributing to the production of high-quality medicines.
• Our client values its employees and provides a supportive and challenging work environment.
• Join our team and play a vital part in ensuring the quality and safety of pharmaceutical products.