About the Role
Our client, a leading pharmaceutical company renowned for its commitment to quality and innovation, is seeking a Senior Pharmaceutical Analytical Chemist to join their expanding team in Klerksdorp, North West. This crucial role will involve the development, validation, and execution of analytical methods used to assess the quality, purity, and stability of pharmaceutical products. You will be instrumental in ensuring that all products meet stringent regulatory standards and internal quality specifications. The successful candidate will possess a strong background in analytical chemistry, particularly as it applies to pharmaceutical analysis, and experience with a wide range of analytical instrumentation. This position in Klerksdorp offers an excellent opportunity to advance your career within a supportive and technologically advanced environment. Our client is dedicated to fostering a culture of scientific rigor and continuous improvement.
Key Responsibilities
- Develop, validate, and transfer analytical methods for raw materials, in-process samples, and finished pharmaceutical products.
- Perform routine and non-routine testing using various analytical techniques, including HPLC, GC, UV-Vis, FT-IR, and dissolution testing.
- Analyze and interpret complex analytical data, troubleshoot method issues, and propose solutions.
- Prepare and review method validation protocols and reports according to ICH and regulatory guidelines.
- Maintain laboratory equipment, ensuring calibration, qualification, and preventative maintenance are performed.
- Author and review analytical sections of regulatory submission documents (e.g., NDAs, ANDAs).
- Collaborate with formulation development, quality control, and quality assurance departments.
- Stay current with scientific literature, regulatory updates, and new analytical technologies.
- Ensure compliance with GMP, GLP, and other relevant quality standards in all laboratory activities.
- Contribute to process improvement initiatives and the implementation of new analytical technologies.
Requirements
- Master's or PhD in Analytical Chemistry, Pharmaceutical Chemistry, or a related scientific discipline.
- Minimum of 5 years of experience in pharmaceutical analytical method development and validation.
- Proficiency in using and troubleshooting common analytical instruments such as HPLC, UPLC, GC, MS, and dissolution apparatus.
- Strong understanding of pharmaceutical quality systems, GMP, and regulatory requirements (ICH, FDA, EMA).
- Experience with pharmacopoeial methods (USP, EP, BP) and compendial testing.
- Excellent data analysis, interpretation, and technical writing skills.
- Ability to work independently and collaboratively in a team environment.
- Strong problem-solving capabilities and attention to detail.
- Good communication and interpersonal skills.
- Experience in stability studies and impurity profiling is highly desirable.
- Must be legally authorized to work in South Africa and reside in or be willing to relocate to the North West region.
Benefits
- Our client offers a competitive salary package, potential for annual performance bonuses, and comprehensive health and retirement benefits.
- Opportunities for professional development, including advanced training programs and conference attendance, are provided.
- The Klerksdorp location offers a pleasant living environment and a strong community.
- Our client promotes a culture of scientific excellence and offers a challenging yet rewarding career path.
- Additional perks may include paid time off, wellness programs, and potential for cross-functional projects.
- This is an excellent opportunity to contribute to a respected pharmaceutical organization in South Africa.