The QC Executive will oversee testing, analysis, and inspection of raw materials, in-process samples, and finished products. This requires strong analytical skills, knowledge of laboratory practices, and adherence to quality and regulatory standards.
Roles and Responsibilities:
- Perform quality control testing of raw materials, in-process samples, and finished products.
- Conduct chemical, instrumental, and microbiological analysis as required.
- Operate and maintain laboratory instruments such as HPLC, UV, IR, and other analytical equipment.
- Ensure compliance with cGMP, GLP, and regulatory guidelines.
- Maintain accurate and complete documentation as per SOPs and quality standards.
- Review and verify test results and ensure data integrity.
- Prepare and update SOPs, specifications, and testing protocols.
- Handle out-of-specification (OOS), out-of-trend (OOT), and deviations.
- Participate in method validation, verification, and transfer activities.
- Ensure proper calibration and maintenance of laboratory instruments.
- Monitor environmental conditions in the laboratory as required.
- Maintain proper storage and handling of samples and chemicals.
- Ensure safety practices, hygiene, and housekeeping in the laboratory.
- Assist in internal and external audits and ensure audit readiness.
- Coordinate with production and QA teams for quality-related issues.
- Conduct stability studies and maintain stability data records.
- Ensure timely release or rejection of materials based on test results.
- Maintain records of standards, reagents, and laboratory consumables.
- Identify areas for process improvement and implement corrective actions.
- Ensure compliance with regulatory authorities and documentation standards.
- Train and guide junior staff or trainees when required.
- Handle multiple tasks efficiently in a time-bound environment.
- Maintain confidentiality and integrity of quality data.
- Stay updated with advancements in quality control practices.
- Contribute to maintaining overall product quality and compliance.