Senior Analytical Chemist - Pharmaceutical Quality Control

Placements24; Stellenbosch; Vor Ort; ZAR 800.000 - 1.100.000; Vollzeit

Benefits dieser Stelle

Medical aid

Retirement fund

Life insurance

Paid time off

Zusammenfassung

Placements24 in Stellenbosch, Western Cape, ZA, seeks a Senior Analytical Chemist to join the Quality Control team. The role emphasizes rigorous testing of raw materials and finished products, adherence to ICH guidelines, and robust data review.

You will mentor juniors and contribute to continuous quality improvements in a state-of-the-art laboratory. The incumbent will lead method development and validation, handle regulatory inspections, and ensure GLP/GMP compliance while advancing public

Qualifikationen

• MSc or PhD in Analytical Chemistry, Pharmaceutical Chemistry, or related field.
• Minimum of 5 years in pharmaceutical analytical development and quality control.
• Extensive hands-on experience with HPLC, GC, UV-Vis, FTIR and related techniques.
• Thorough understanding of method validation, ICH guidelines, and regulatory requirements (FDA/EMA).
• Experience with LIMS and regulatory inspections/audits.

Aufgaben

• Perform routine/non-routine analytical testing on materials and finished products using HPLC, GC, UV-Vis, KF, etc.
• Develop, validate, and transfer analytical methods per ICH guidelines.
• Troubleshoot instrumentation and resolve issues promptly.
• Review/approve analytical data for accuracy and completeness.
• Participate in regulatory inspections and internal audits.
• Investigate OOS results and implement CAPAs.
• Maintain GLP/GMP and train junior chemists.
• Prepare technical reports for regulatory submissions.

Kenntnisse

Analytical chemistry

Regulatory compliance

Method development & validation

OOS investigation & CAPA

GLP/GMP knowledge

Ausbildung

MSc or PhD in Analytical/Pharmaceutical Chemistry

Tools

HPLC

GC

UV-Vis

FTIR

LIMS

Jobbeschreibung

About the Role Our client, a renowned pharmaceutical company, is seeking a dedicated Senior Analytical Chemist to join their Quality Control department. This role is crucial for ensuring the safety, efficacy, and quality of pharmaceutical products through rigorous testing and analysis. The state-of-the-art laboratory facilities in Stellenbosch, Western Cape, ZA are equipped with advanced instrumentation necessary for comprehensive quality assurance. We are looking for a meticulous scientist with a strong understanding of analytical techniques and regulatory compliance within the pharmaceutical industry. This position offers a challenging and rewarding opportunity to contribute to public health within the Stellenbosch, Western Cape, ZA region.

Key Responsibilities

• Perform routine and non-routine analytical testing on raw materials, intermediates, and finished pharmaceutical products using various techniques (HPLC, GC, UV-Vis, KF, etc.).
• Develop, validate, and transfer analytical methods according to ICH guidelines and regulatory requirements.
• Troubleshoot analytical instrumentation and resolve analytical issues promptly.
• Review and approve analytical data, ensuring accuracy and completeness.
• Participate in regulatory inspections and internal audits.
• Investigate out-of-specification (OOS) results and implement corrective and preventive actions (CAPAs).
• Maintain laboratory equipment and ensure compliance with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).
• Train and mentor junior analytical chemists.
• Contribute to continuous improvement initiatives within the QC laboratory.
• Prepare technical reports and documentation for regulatory submissions.

Requirements

• M.Sc. or Ph.D. in Analytical Chemistry, Pharmaceutical Chemistry, or a related scientific discipline.
• Minimum of 5 years of experience in pharmaceutical analytical development and quality control.
• Extensive hands-on experience with HPLC, GC, and other relevant analytical techniques.
• Thorough understanding of method validation, ICH guidelines, and regulatory requirements (e.g., FDA, EMA).
• Experience with spectroscopic techniques (UV-Vis, FTIR) and wet chemistry methods.
• Proficiency in laboratory information management systems (LIMS).
• Strong problem-solving skills and attention to detail.
• Excellent written and verbal communication skills.
• Ability to work independently and as part of a collaborative team.
• Experience with OOS investigations and CAPA management.

Benefits

• Our client offers a competitive salary, performance-based bonuses, and a comprehensive benefits package including medical aid, life insurance, and a retirement fund.
• Opportunities for professional growth through training programs and conference attendance are provided.
• The Stellenbosch, Western Cape, ZA location offers a pleasant working environment.
• We foster a culture of quality, integrity, and continuous improvement.
• Paid time off and support for work-life balance are prioritized.
• Join a trusted organization committed to producing high-quality pharmaceuticals and advancing healthcare.