Senior QC Analyst - GMP, Method Validation & Analytics

Placements24

Rustenburg

On-site

ZAR 700,000 - 950,000

Full time

3 days ago
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Benefits offered by this job

Competitive salary package
Comprehensive health insurance
Pension fund participation
Paid annual and sick leave
Professional development opportunities
Modern, well-equipped laboratory

Job summary

Placements24 is seeking a Senior Quality Control Analyst in Rustenburg, North West to perform routine and non-routine analytical testing on raw materials, intermediates, and finished products using techniques including HPLC, GC, UV-Vis, IR, and KF Titration. The role emphasizes method validation, instrument calibration, and GMP compliance.

The candidate should hold a BSc/MSc in Chemistry, Pharmacy, Biochemistry or related field with at least 5 years of QC experience in pharma, strong

Qualifications

  • Bachelor's or Master's degree in Chemistry, Pharmacy, Biochemistry, or a related scientific field.
  • Minimum of 5 years of experience in pharmaceutical Quality Control.
  • Proficiency in using analytical instrumentation such as HPLC, GC, Dissolution Testers, and Spectrophotometers.
  • In-depth knowledge of GMP, ICH guidelines, and pharmacopoeial standards (e.g., USP, EP, BP).
  • Experience with method validation and OOS investigations.
  • Excellent documentation and record-keeping skills.
  • Strong analytical and problem-solving abilities.

Responsibilities

  • Perform routine and non-routine analytical testing on raw materials, intermediates, and finished pharmaceutical products using various techniques (e.g., HPLC, GC, UV-Vis, IR, KF Titration).
  • Develop, validate, and transfer analytical methods according to regulatory guidelines.
  • Calibrate and maintain laboratory instruments, ensuring their proper functioning and accuracy.
  • Review and interpret analytical data, documenting results accurately and thoroughly in compliance with GMP.
  • Investigate Out-of-Specification (OOS) results and deviations, participating in root cause analysis and implementing corrective actions.
  • Prepare Certificates of Analysis (CoA) for released batches.
  • Ensure compliance with all relevant quality standards, GMP guidelines, and internal SOPs.
  • Train and mentor junior QC analysts, providing technical guidance and support.
  • Participate in internal and external audits as required.
  • Contribute to continuous improvement initiatives within the Quality Control department.

Skills

Attention to detail
Analytical thinking
Problem-solving
Teamwork
Independent work

Education

Chemistry/Pharmacy/Biochemistry degree

Tools

HPLC
GC
Dissolution testers
Spectrophotometers

Job description

Placements24 is seeking a Senior Quality Control Analyst in Rustenburg, North West to perform routine and non-routine analytical testing on raw materials, intermediates, and finished products using techniques including HPLC, GC, UV-Vis, IR, and KF Titration. The role emphasizes method validation, instrument calibration, and GMP compliance.

The candidate should hold a BSc/MSc in Chemistry, Pharmacy, Biochemistry or related field with at least 5 years of QC experience in pharma, strong

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