Senior Pharmaceutical Quality Control Analyst

Placements24; Mtubatuba Local Municipality; On-site; ZAR 850,000 - 1,150,000; Full time

Benefits offered by this job

Competitive salary

Health/dental/vision insurance

Paid time off & holidays

Professional development

Pension fund contributions

Performance-based bonuses

Job summary

Placements24 is seeking a Senior Pharmaceutical Quality Control Analyst to join a leading pharmaceutical innovator in Richards Bay, KwaZulu-Natal. You will conduct comprehensive analytical testing (HPLC, GC, UV-Vis, dissolution), develop and validate methods, and ensure GLP/GMP compliance.

The role involves investigation of OOS results and CAPA, data review, and cross-functional collaboration with R&D, Manufacturing and Regulatory Affairs.

Qualifications

• Bachelor’s or Master’s degree in Pharmacy, Chemistry, Biochemistry, or life science.
• Minimum 5 years’ progressive experience in pharmaceutical quality control or analytical development.
• Knowledge of ICH guidelines and regulatory requirements (FDA/EMA/SAHPRA).
• Proficiency with HPLC/GC systems and GLP/GMP standards.

Responsibilities

• Conduct analytical testing of raw materials, in-process samples and finished products using HPLC, GC, UV-Vis and dissolution methods.
• Develop, validate and transfer analytical methods per ICH guidelines.
• Calibrate, maintain and troubleshoot instruments to ensure accuracy.
• Document all laboratory activities in GLP/GMP compliant records.
• Investigate OOS results and deviations; perform root cause analysis and CAPAs.

Skills

HPLC testing

GC testing

UV-Vis spectroscopy

Dissolution testing

Method validation

GMP/GLP compliance

CAPA investigation

Data integrity

Cross-functional collaboration

Analytical problem solving

Education

Bachelor’s or Master’s in Pharmacy/Chemistry/Biochemistry

Tools

HPLC equipment

GC equipment

UV-Vis spectrophotometer

Dissolution apparatus

Job description

About the Role

Our client, a leading pharmaceutical innovator, is seeking a highly motivated and detail-oriented Senior Pharmaceutical Quality Control Analyst to join their dynamic team in Richards Bay, KwaZulu-Natal . This role is critical in ensuring the consistent quality and safety of our manufactured pharmaceutical products. The successful candidate will be instrumental in upholding stringent regulatory standards and contributing to the overall success of our quality assurance initiatives. This is an exciting opportunity to advance your career within a reputable organization that values scientific excellence and professional growth. We are committed to fostering an environment where innovation thrives and our employees are empowered to make a significant impact in the healthcare sector. This position requires a strong understanding of analytical techniques and pharmaceutical manufacturing processes.

Key Responsibilities

• Conduct comprehensive analytical testing of raw materials, in-process samples, and finished pharmaceutical products using various techniques such as HPLC, GC, UV-Vis spectroscopy, and dissolution testing.
• Develop, validate, and transfer analytical methods according to ICH guidelines and regulatory requirements.
• Perform instrument calibration, maintenance, and troubleshooting to ensure optimal performance and accuracy.
• Document all laboratory activities, results, and deviations meticulously in compliance with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).
• Investigate out-of-specification (OOS) results and deviations, providing thorough root cause analysis and recommending corrective and preventive actions (CAPAs).
• Review and approve analytical data, reports, and specifications.
• Collaborate effectively with cross-functional teams, including R&D, Manufacturing, and Regulatory Affairs, to resolve quality issues.
• Contribute to the continuous improvement of quality control processes and procedures.
• Mentor and train junior analysts on laboratory techniques, equipment operation, and compliance requirements.

Requirements

• Bachelor's degree or Master's degree in Pharmacy, Chemistry, Biochemistry, or a related life science field.
• A minimum of 5 years of progressive experience in pharmaceutical quality control or analytical development.
• In-depth knowledge of pharmaceutical manufacturing processes, quality systems, and regulatory guidelines (e.g., FDA, EMA, SAHPRA).
• Proficiency in operating and maintaining standard laboratory equipment, particularly HPLC and GC systems.
• Strong understanding of method validation, stability testing, and OOS investigations.
• Excellent analytical, problem-solving, and critical thinking skills.
• Exceptional attention to detail and commitment to accuracy.
• Effective communication and interpersonal skills, with the ability to work collaboratively in a team environment.
• Experience with quality risk management principles is advantageous.

Benefits

• Competitive annual salary commensurate with experience.
• Comprehensive health, dental, and vision insurance plans.
• Generous paid time off and company holidays.
• Opportunities for professional development, training, and career advancement within a growing company.
• A supportive and collaborative work environment focused on innovation and quality.
• Pension fund contributions and other retirement benefits.
• Potential for performance-based bonuses.