Senior Quality Control Analyst - Pharmaceuticals

Placements24; Rustenburg; On-site; ZAR 700,000 - 950,000; Full time

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

About the Role

Our client, a reputable pharmaceutical company, is looking for a dedicated Senior Quality Control Analyst to join their team in Rustenburg, North West . This role is crucial for ensuring the quality and safety of pharmaceutical products manufactured by our client. You will be responsible for performing a wide range of analytical tests on raw materials, in-process samples, and finished products using advanced laboratory equipment. The Senior Quality Control Analyst will play a key role in method validation, instrument calibration, and maintaining compliance with Good Manufacturing Practices (GMP) and other regulatory standards. This position requires meticulous attention to detail, strong analytical skills, and a thorough understanding of pharmaceutical quality control principles. The successful candidate will contribute to maintaining the highest standards of product integrity and play a vital part in the company's commitment to delivering safe and effective medicines. This is an excellent opportunity for an experienced QC professional to advance their career within a growing organization. You will work within a well-equipped laboratory environment and collaborate with a team dedicated to excellence in pharmaceutical quality.

Key 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.

Requirements

• 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, with a strong understanding of analytical techniques.
• 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.
• Ability to work independently and as part of a team.
• Good interpersonal and communication skills.
• Detail-oriented with a high level of accuracy.

Benefits

• Competitive salary package.
• Performance incentives.
• Comprehensive health insurance coverage.
• Pension fund participation.
• Paid annual leave and sick leave.
• Opportunities for professional development and training.
• Work in a modern, well-equipped laboratory.
• Contribute to the production of vital medicines.