About the Role
Our client, a prominent pharmaceutical company based in Midrand, Gauteng, ZA, is seeking an experienced and highly skilled Lead Analytical Chemist to oversee their Quality Control laboratory. This role is integral to ensuring the consistent quality and safety of our client's pharmaceutical products. You will lead a team of dedicated chemists, implement rigorous analytical testing protocols, and ensure compliance with all regulatory standards. This hybrid position offers a blend of on-site laboratory work and remote coordination, providing a dynamic work environment. The successful candidate will possess deep expertise in analytical chemistry techniques relevant to pharmaceuticals and a strong leadership aptitude. This is a critical role that directly impacts product integrity and patient safety.
Key Responsibilities
- Lead, train, and mentor a team of analytical chemists in the Quality Control department.
- Develop, validate, and implement analytical methods for raw materials, in-process samples, and finished pharmaceutical products using techniques such as HPLC, GC, UV-Vis, FTIR, and dissolution testing.
- Oversee the day-to-day operations of the QC laboratory, ensuring efficient workflow and timely analysis of samples.
- Interpret complex analytical data, investigate out-of-specification (OOS) results, and implement corrective and preventive actions (CAPAs).
- Ensure compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and relevant regulatory guidelines (e.g., SAHPRA, FDA, EMA).
- Manage laboratory equipment, including calibration, maintenance, and qualification.
- Prepare and review analytical reports, method validation protocols, and other quality documentation.
- Collaborate with R&D, Production, and Regulatory Affairs departments to address quality-related issues and support product lifecycle management.
- Contribute to process improvement initiatives within the Quality Control function.
- Participate in audits from regulatory agencies and external partners.
Requirements
- M.Sc. or Ph.D. in Analytical Chemistry, Pharmaceutical Chemistry, or a related discipline.
- Minimum of 8 years of progressive experience in pharmaceutical analytical development and Quality Control, with at least 3 years in a supervisory or leadership role.
- Extensive hands-on experience with chromatographic techniques (HPLC, GC) and spectroscopic methods.
- Thorough understanding of pharmaceutical regulatory requirements and quality systems.
- Proven ability to troubleshoot analytical methods and instrumentation.
- Strong leadership, communication, and interpersonal skills.
- Experience with laboratory information management systems (LIMS).
- Ability to work effectively in both independent and team settings.
- Must be willing to work on-site in Midrand, Gauteng, ZA for a significant portion of the week, with flexibility for remote work.
Benefits
- This position offers a competitive salary and comprehensive benefits package.
- Enjoy opportunities for professional growth and development within a leading pharmaceutical organization.
- Contribute to a vital aspect of drug manufacturing and quality assurance.
- Be part of a collaborative team environment that values scientific excellence and continuous improvement.
- Access to state-of-the-art laboratory facilities and equipment.
- This hybrid role provides a balance between on-site engagement and remote flexibility, fostering a productive work environment.
- Opportunities to lead and shape the future of quality control within the organization.