QC Supervisor

Division Overview

Aurolife was founded in 2008 as part of a group of companies that has a long history of excelling in generic pharmaceutical product development and manufacturing. Aurolife has a 10‑year history of extraordinary manufacturing practices in the solid oral dose arena. The support and expertise of our parent organization has given Aurolife a jump start in building a solid pharmaceutical portfolio very quickly.

The Aurolife family consists of an experienced management team with expertise in manufacturing, R&D, Quality Assurance, Quality Control and regulatory affairs. In addition to several formulations under manufacture, we have a robust pipeline of products. Aurolife's aim is to provide healthcare at economical prices to make this a healthier world to live in.

The QC Supervisor focuses on the Quality Control Laboratory, offering project and task management along with technical leadership. The incumbent is tasked with ensuring QC testing is conducted in accordance with established procedures and guidelines. Moreover, they are entrusted with providing training, facilitating development, and offering necessary resources, information, and guidance. The QC Supervisor assumes responsibility for managing and coaching team members.

Leveraging their technical expertise and knowledge of pharmaceutical testing—including critical issues related to test methods, laboratory instrumentation, and operational principles—and staying updated on current regulatory guidelines, they ensure the safe, efficient, and effective functioning of laboratory operations. This role plays a crucial part within the QC department, ensuring that team activities comply with relevant rules and regulations, such as current USP‑NF, cGMP, safety protocols, in‑house SOPs, and testing procedures.

• Leading a quality control team and managing the associated lab focused on Aurolife Unit‑2.
• Planning, organizing, and scheduling activities based on business needs.
• Supervising daily operations: overseeing the quality control department’s day‑to‑day operations.
• Responsible for data integrity compliance and laboratory GLP/cGMP/GxP compliance.
• Ensuring the accuracy of analytical measurements and compliance with cGMP, US FDA, and other regulatory and corporate requirements.
• Conducting troubleshooting and investigations using critical thinking skills and creativity in problem‑solving.
• Overseeing analytical method transfers and method verifications.
• Preparing and reviewing test procedures, SOPs, protocols, and reports.
• Reviewing analytical data generated in the laboratory for accuracy and adherence to documentation requirements; compiling data and trend summaries for regulatory submission.
• Communicating and coordinating activities with other departments such as manufacturing, Quality Assurance, and R&D.
• Providing status updates to management and promptly communicating any observed technical or scheduling problems.
• Taking the lead on special tasks assigned by management.
• Preparing for internal and external audits such as pre‑approval, cGMP, and post‑approval inspections by the US FDA.
• Other tasks as assigned.

• Minimum of 8 to 10 years of experience in the pharmaceutical industry, preferably with 3 to 5 years of experience in drug‑device combination product pharmaceuticals.
• Experience in release and stability testing of metered dose inhalers, transdermal and topicals, including chromatographic and product performance testing. Relevant experience should include tests such as aerodynamic particle size by cascade impactor, dose content uniformity, spray pattern, moisture content, assay and impurities, and excipient content. Transdermal physical and chemical testing.
• Knowledge and experience in method transfer and validation, with prior supervisory roles being advantageous.
• Familiarity with pharmaceutical regulatory standards, including USP/ICH/FDA 21 CFR 210/211, CFR 11 & CFR 820/ISO 13485/cGMP/safety, etc.
• Experience in leading a team and managing a lab in a fast‑paced environment.
• Expert organizational and project management capabilities. Strong oral and written communication skills.
• Desirable…