About the Role
Our client, a leading pharmaceutical research and manufacturing company, is seeking a highly skilled Senior Analytical Scientist to join their Quality Control and Assurance department in Upington, Northern Cape . This role is critical for ensuring the quality, safety, and efficacy of our pharmaceutical products through rigorous analytical testing and method development. You will be responsible for leading analytical projects, developing and validating new analytical methods, and troubleshooting complex analytical challenges. The ideal candidate will possess extensive experience with a wide range of analytical techniques, a deep understanding of regulatory requirements (e.g., GMP, ICH), and a commitment to scientific excellence. This is an exciting opportunity to contribute to the development and release of vital medicines, working within a dedicated team that upholds the highest standards of quality. You will play a key role in ensuring product integrity and compliance. The position requires a meticulous and experienced scientist eager to make a significant impact in the pharmaceutical industry in the Northern Cape .
Key Responsibilities
- Develop, validate, and implement analytical methods for raw materials, in-process samples, and finished pharmaceutical products using techniques such as HPLC, GC, MS, UV-Vis, FTIR, and dissolution testing.
- Perform routine and non-routine analytical testing according to established SOPs and regulatory guidelines.
- Troubleshoot and resolve analytical issues encountered during method development, validation, or routine testing.
- Conduct stability studies and analyze data to determine product shelf-life and storage conditions.
- Interpret complex analytical data and generate comprehensive reports.
- Ensure compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other relevant regulatory requirements.
- Maintain laboratory equipment, including calibration, qualification, and preventative maintenance.
- Mentor and provide technical guidance to junior analytical chemists and technicians.
- Participate in internal and external audits as an analytical subject matter expert.
- Contribute to the continuous improvement of analytical processes and methodologies.
- Stay updated with the latest advancements in analytical chemistry and pharmaceutical regulations.
Requirements
- M.Sc. or Ph.D. in Analytical Chemistry, Organic Chemistry, Pharmaceutical Sciences, or a related field.
- Minimum of 5 years of experience in analytical development and quality control within the pharmaceutical industry.
- Extensive hands-on experience with HPLC, GC, Mass Spectrometry, and other relevant analytical techniques.
- Strong understanding of method validation principles and ICH guidelines.
- Proven ability to develop, troubleshoot, and optimize analytical methods.
- Proficiency in data analysis and interpretation using relevant software (e.g., Empower, ChemStation).
- Excellent knowledge of GMP and regulatory compliance requirements.
- Strong problem-solving skills and attention to detail.
- Effective written and verbal communication skills.
- Ability to work independently and as part of a collaborative team.
- Experience in leading analytical projects is a significant advantage.
Benefits
- Competitive salary and bonus structure.
- Comprehensive medical, dental, and vision insurance.
- Retirement savings plan with company contributions.
- Generous paid time off and company holidays.
- Opportunities for professional development, including specialized training and conference attendance.
- Access to modern analytical instrumentation and facilities in Upington .
- A supportive and quality-focused work environment.
- Potential for career advancement within the organization.
- Relocation assistance may be available.