Senior Pharmaceutical Quality Control Analyst - Pietermaritzburg

Placements24; Pietermaritzburg; Hybride; ZAR 600 000 - 900 000; Plein temps

Avantages offerts par ce poste

Competitive remuneration package

Medical aid plan

Retirement fund

Performance-based bonuses

Training and development opportunities

Career advancement opportunities

Résumé du poste

Placements24 is seeking a highly skilled Senior Pharmaceutical Quality Control Analyst to join the team in Pietermaritzburg. The role focuses on analytical testing across raw materials, in-process samples, and finished products to ensure regulatory compliance and product quality.

You will develop and validate analytical methods, investigate OOS results, and maintain GLP/GMP-compliant records while collaborating with R&D, Manufacturing, and Regulatory Affairs to support the product lifecycle.

Qualifications

• Bachelor's or Master's degree in Pharmacy, Chemistry, or a related scientific discipline.
• Minimum of 5 years of progressive experience in pharmaceutical quality control or quality assurance.
• Proven expertise in operating and maintaining analytical instruments such as HPLC, GC, dissolution testers, and spectrophotometers.
• Thorough understanding of pharmaceutical regulatory requirements (SAHPRA, ICH, GMP, GLP).
• Experience in method development and validation is highly desirable.
• Strong analytical and problem-solving skills, with a proven ability to investigate and resolve complex technical issues.
• Excellent written and verbal communication skills, with the ability to clearly document findings and present technical information.
• Proficiency in data analysis and interpretation, with a meticulous approach to record-keeping.
• Familiarity with LIMS is a plus.

Responsabilités

• Perform analytical tests on raw materials, in-process samples, and finished pharmaceutical products using analytical instrumentation (e.g., HPLC, GC, UV-Vis, FTIR).
• Develop, validate, and transfer analytical methods in accordance with regulatory guidelines (e.g., ICH, FDA, SAHPRA).
• Investigate out-of-specification (OOS) results, identify root causes, and implement CAPAs.
• Maintain accurate and detailed laboratory records, ensuring compliance with GLP and GMP.
• Prepare and review analytical reports, certificates of analysis (CoAs), and other quality documentation.
• Calibrate and maintain laboratory equipment, ensuring its optimal performance and accuracy.
• Collaborate with cross-functional teams, including R&D, Manufacturing, and Regulatory Affairs, to resolve quality issues and support product lifecycle management.
• Stay updated with the latest scientific advancements, regulatory changes, and industry best practices in pharmaceutical quality control.
• Mentor and train junior analysts, fostering a culture of continuous improvement and knowledge sharing within the QC department.

Connaissances

Analytical chemistry

Problem solving

Data analysis

Independent worker

Team collaboration

Formation

Bachelor's or Master's in Pharmacy or Chemistry

Outils

LIMS

Description du poste

About the Role

Our client, a leading name in the pharmaceutical industry, is seeking a highly skilled and meticulous Senior Pharmaceutical Quality Control Analyst to join their dynamic team in Pietermaritzburg . This is an exciting opportunity to contribute to the development and assurance of high-quality pharmaceutical products that meet stringent regulatory standards. The ideal candidate will possess a strong foundation in analytical chemistry, extensive experience with various quality control techniques, and a keen eye for detail. You will play a pivotal role in ensuring the safety, efficacy, and compliance of our client's diverse product portfolio. This role offers a challenging yet rewarding environment where your expertise will be valued and contribute directly to patient well-being. We are committed to fostering a collaborative work environment that encourages professional growth and development within the pharmaceutical sector.

Key Responsibilities

• Perform a wide range of analytical tests on raw materials, in-process samples, and finished pharmaceutical products using advanced laboratory instrumentation (e.g., HPLC, GC, UV-Vis, FTIR).


• Develop, validate, and transfer analytical methods in accordance with regulatory guidelines (e.g., ICH, FDA, SAHPRA).


• Investigate out-of-specification (OOS) results, identify root causes, and implement corrective and preventive actions (CAPAs).


• Maintain accurate and detailed laboratory records, ensuring compliance with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).


• Prepare and review analytical reports, certificates of analysis (CoAs), and other quality documentation.


• Calibrate and maintain laboratory equipment, ensuring its optimal performance and accuracy.


• Collaborate with cross-functional teams, including R&D, Manufacturing, and Regulatory Affairs, to resolve quality issues and support product lifecycle management.


• Stay updated with the latest scientific advancements, regulatory changes, and industry best practices in pharmaceutical quality control.


• Mentor and train junior analysts, fostering a culture of continuous improvement and knowledge sharing within the QC department.

Requirements

• Bachelor's or Master's degree in Pharmacy, Chemistry, or a related scientific discipline.


• Minimum of 5 years of progressive experience in pharmaceutical quality control or quality assurance.


• Proven expertise in operating and maintaining analytical instruments such as HPLC, GC, dissolution testers, and spectrophotometers.


• Thorough understanding of pharmaceutical regulatory requirements (SAHPRA, ICH, GMP, GLP).


• Experience in method development and validation is highly desirable.


• Strong analytical and problem-solving skills, with a proven ability to investigate and resolve complex technical issues.


• Excellent written and verbal communication skills, with the ability to clearly document findings and present technical information.


• Proficiency in data analysis and interpretation, with a meticulous approach to record-keeping.


• Ability to work independently and as part of a team in a fast-paced environment.


• Familiarity with LIMS (Laboratory Information Management System) is a plus.

Benefits

• Our client offers a competitive remuneration package commensurate with experience and qualifications.


• This includes a comprehensive medical aid plan, a retirement fund, and performance-based bonuses.


• Employees benefit from extensive training and professional development opportunities, including support for further studies and conference attendance.


• We provide a supportive and inclusive work environment with opportunities for career advancement within the pharmaceutical sector.


• The position is based in the scenic city of Pietermaritzburg , offering a great work-life balance.