Senior Quality Control Analyst - Pharmaceutical

Placements24; Centurion; Hybrid; ZAR 700,000 - 900,000; Full time

Benefits offered by this job

Competitive salary

Health insurance

Retirement benefits

Career development

Leave policy

Job summary

Placements24 in Centurion, Gauteng is seeking a Senior Quality Control Analyst to lead analytical activities in a state-of-the-art lab. You will perform complex testing on raw materials and finished products using HPLC, GC, UV-Vis and other techniques, ensuring compliance with cGMP.

The role combines hands-on analysis with mentorship of junior analysts, method validation, data review, and collaboration with Production, R&D and Regulatory Affairs to ensure high-quality pharmaceutical products.

Qualifications

• Bachelor's or Master's in Chemistry or Pharmaceutical Sciences.
• 5+ years in QA/QC in pharma.
• Experience with HPLC, GC, UV-Vis, IR, dissolution testing.
• Strong cGMP and regulatory knowledge (FDA, SAHPRA).
• Excellent analytical and problem-solving skills.
• Data analysis and reporting proficiency.
• Strong communication and collaboration.
• Ability to manage multiple priorities and work independently.
• Experience with method validation/development is advantageous.

Responsibilities

• Perform complex analytical testing on materials and finished products using HPLC, GC, and spectrophotometry.
• Develop, validate, and transfer analytical methods per ICH.
• Investigate OOS results, deviations, CAPAs.
• Review and approve data, batch records, and QC docs.
• Calibrate and qualify laboratory equipment.
• Train and mentor junior analysts.
• Collaborate with Production, R&D, Regulatory Affairs.
• Stay updated with cGMP and pharma regulations.
• Participate in internal and external audits as SME.

Skills

HPLC

GC

Spectrophotometry

Dissolution testing

cGMP knowledge

Regulatory compliance

Data analysis

Communication

Education

Chemistry or Pharmaceutical Sciences degree

Tools

HPLC

GC

UV-Vis

IR

Dissolution testing

Job description

About the Role

Our client, a leading player in the pharmaceutical industry, is seeking a highly motivated and experienced Senior Quality Control Analyst to join their dynamic team in Centurion, Gauteng. This is an exciting opportunity to contribute to the development and release of high-quality pharmaceutical products, ensuring compliance with stringent regulatory standards. You will be instrumental in maintaining the integrity and safety of our client's offerings, working within a state-of-the-art laboratory environment. The role offers a blend of hands-on analytical work and leadership, making it ideal for a professional looking to advance their career in pharmaceutical quality control. The successful candidate will uphold the highest standards of scientific practice and contribute to a culture of continuous improvement within the quality department.

Key Responsibilities

• Perform complex analytical testing on raw materials, in-process samples, and finished pharmaceutical products using advanced instrumentation (e.g., HPLC, GC, Spectrophotometry).
• Develop, validate, and transfer analytical methods according to regulatory guidelines (e.g., ICH).
• Investigate out-of-specification (OOS) results, deviations, and customer complaints, identifying root causes and implementing corrective and preventative actions (CAPAs).
• Review and approve analytical data, batch records, and quality control documentation.
• Contribute to the qualification and calibration of laboratory equipment.
• Train and mentor junior analysts, providing guidance and technical support.
• Collaborate with cross-functional teams, including Production, R&D, and Regulatory Affairs, to resolve quality issues.
• Stay abreast of current Good Manufacturing Practices (cGMP) and relevant pharmaceutical regulations.
• Participate in internal and external audits as a subject matter expert.

Requirements

• Bachelor's or Master's degree in Chemistry, Pharmaceutical Sciences, or a related field.
• Minimum of 5 years of experience in a Quality Control role within the pharmaceutical industry.
• Proven experience with analytical techniques such as HPLC, GC, UV-Vis, IR, and dissolution testing.
• Strong understanding of cGMP, regulatory requirements (e.g., FDA, SAHPRA), and quality management systems.
• Excellent problem-solving and analytical skills with a meticulous attention to detail.
• Proficiency in data analysis and reporting.
• Strong communication and interpersonal skills, with the ability to effectively collaborate with team members and stakeholders.
• Demonstrated ability to work independently and manage multiple priorities in a fast-paced environment.
• Experience with method validation and development is highly advantageous.

Benefits

• Competitive salary commensurate with experience.
• Comprehensive health insurance and retirement benefits.
• Opportunities for professional development and career advancement within a growing company.
• A collaborative and supportive work environment in Centurion, Gauteng.
• Access to cutting-edge technology and laboratory facilities.
• Generous leave policy.
• Contribute to the production of life-saving and life-enhancing medications.