- Develop, review, and maintain SOPs for raw and packaging materials.
- Supervise the sampling and testing of raw materials, packaging components, and water samples.
- Operate and calibrate key instruments, such as HPLC and GC, used for raw material analysis.
- Prepare and document analytical and calibration reports accurately and in a timely manner.
- Ensure the proper cleaning and upkeep of QC laboratory equipment and facilities.
- Monitor and maintain records of reference and working standards, ensuring adherence to internal SOPs.
- Manage primary standards and oversee analytical method transfers for APIs, including preparation of related protocols and reports.
- Oversee the storage, handling, and disposal of chemicals, glassware, and control samples.
- Mentor, train, and evaluate raw material analysts and technicians to enhance team performance.
- Ensure cGMP compliance across all activities within the Raw Material section.
- Investigate and address OOS (Out of Specification) and OOT (Out of Trend) results effectively.
- Monitor environmental conditions such as temperature and humidity within the QC department.
- Validate analytical methods for raw materials and APIs, from protocol development to final reporting.
- Implement safety measures, conduct risk assessments, and promote a culture of compliance with EHS regulations.
- Participate in accident investigations and implement preventive measures to ensure workplace safety.
Bachelor’s degree in Pharmacy or Sciences.+7 years in a reputable pharmaceutical company with substantial expertise in raw material quality control.In-depth knowledge of SOP control, QMS processes, batch release systems, and documentation management for SPCs, STPs, and worksheets.Hands-on experience with operating and calibrating advanced laboratory instruments, including HPLC and GC.Strong leadership and people management skills, with the ability to set goals and organize resources efficiently.