Senior Quality Control Analyst - Pharmaceutical

Placements24; Kimberley; On-site; CAD 52,000 - 77,000; Full time

Benefits offered by this job

Medical aid

Provident fund

Life insurance

Job summary

Placements24 seeks a Senior Quality Control Analyst for its pharmaceutical laboratory in Kimberley, Northern Cape. The role involves rigorous analytical testing of raw materials, in-process samples, and finished products using HPLC, GC, UV-Vis, and FTIR, with a strong emphasis on GMP compliance and data integrity.

The successful candidate will lead method development/validation, troubleshoot instruments, and mentor junior staff in a regulated setting.

Qualifications

• Minimum 7 years of experience as a Quality Control Analyst in the pharmaceutical industry.
• Extensive hands-on experience with analytical instrumentation such as HPLC, GC, spectrophotometers, and dissolution testers.
• Strong understanding of GMP and regulatory requirements for pharmaceuticals.
• Proficiency in analytical method development and validation.
• Excellent analytical, problem-solving, and critical-thinking skills.
• Meticulous attention to detail and accuracy in data recording and reporting.
• Strong written and verbal communication skills.

Responsibilities

• Perform quantitative and qualitative analytical testing on materials and finished products using various laboratory techniques and instrumentation (e.g., HPLC, GC, UV-Vis, FTIR).
• Analyze test results, compare them against established specifications, and document findings accurately.
• Identify and investigate out-of-specification (OOS) results, ensuring root cause analysis and corrective actions.
• Calibrate, maintain, and troubleshoot analytical instruments to ensure optimal performance and accuracy.
• Prepare analytical methods, validation protocols, and reports in accordance with cGMP guidelines.
• Participate in stability testing programs and environmental monitoring.
• Ensure compliance with regulatory requirements (FDA, SAHPRA) and internal quality procedures.
• Contribute to continuous improvement of laboratory processes and methodologies.
• Train and mentor junior analysts on laboratory techniques and procedures.
• Maintain a clean, organized, and safe laboratory environment.

Skills

Analytical thinking

Problem solving

Attention to detail

Communication

Teamwork

Education

Bachelor's or Master's in Chemistry/Pharmacy

Tools

HPLC

GC

UV-Vis

FTIR

Dissolution testing

LIMS

Job description

About the Role

Our client, a leading pharmaceutical manufacturer, is seeking a highly skilled and meticulous Senior Quality Control Analyst to join their esteemed laboratory team in Kimberley, Northern Cape . This critical role involves performing a wide range of analytical tests on raw materials, in-process samples, and finished pharmaceutical products to ensure they meet stringent quality and regulatory standards. You will play a key part in maintaining the integrity and safety of our client's life-saving medications. The ideal candidate will possess a strong background in pharmaceutical analysis, extensive experience with analytical instrumentation, and a deep understanding of GMP and regulatory guidelines. This is an excellent opportunity for a seasoned analyst to advance their career in a vital industry.

Key Responsibilities

Perform quantitative and qualitative analytical testing on raw materials, intermediates, and finished products using various laboratory techniques and instrumentation (e.g., HPLC, GC, UV-Vis, FTIR). Analyze test results, compare them against established specifications, and document findings accurately. Identify and investigate out-of-specification (OOS) results, ensuring proper root cause analysis and corrective actions are implemented. Calibrate, maintain, and troubleshoot analytical instruments to ensure optimal performance and accuracy. Prepare analytical methods, validation protocols, and reports in accordance with cGMP guidelines. Participate in stability testing programs and environmental monitoring. Ensure compliance with all relevant regulatory requirements (e.g., FDA, SAHPRA) and internal quality procedures. Contribute to the continuous improvement of laboratory processes and methodologies. Train and mentor junior analysts on laboratory techniques and procedures. Maintain a clean, organized, and safe laboratory environment.

Requirements

Bachelor's or Master's degree in Chemistry, Pharmacy, or a related scientific discipline. Minimum of 7 years of experience as a Quality Control Analyst in the pharmaceutical industry. Extensive hands-on experience with analytical instrumentation such as HPLC, GC, spectrophotometers, and dissolution testers. Strong understanding of Good Manufacturing Practices (GMP) and regulatory requirements for pharmaceuticals. Proficiency in analytical method development and validation. Excellent analytical, problem-solving, and critical-thinking skills. Meticulous attention to detail and accuracy in data recording and reporting. Strong written and verbal communication skills. Ability to work independently and as part of a team in a regulated laboratory environment. Experience with LIMS (Laboratory Information Management System) is a plus.

Benefits

Our client offers a highly competitive salary, commensurate with experience, and a comprehensive benefits package including excellent medical aid, a generous provident fund, and life insurance. Opportunities for professional growth and development, including further training and conference attendance, are actively supported. The work environment in Kimberley, Northern Cape , is focused on scientific rigor and collaboration. Join a company dedicated to producing high-quality pharmaceuticals and improving patient health. This role offers a significant opportunity to contribute to the pharmaceutical sector's advancement.