Senior Quality Control Analyst

As a Technical Expertise professional, you will be required to have hands-on experience with analytical instruments such as HPLC, UV, IR, and GC. It is essential to have a strong understanding of GMP compliance and adhere to Data Integrity principles like ALCOA/ALCOA+. In your role, you will face audits from regulatory bodies like USFDA, MHRA, WHO, GMP, and ISO. Your responsibilities will include supporting audit preparedness, documentation, and implementing CAPA. Your key responsibilities will involve: - Performing routine and non-routine analysis of raw materials, in-process samples, finished products, and stability samples. - Operating, calibrating, and troubleshooting analytical instruments like HPLC, UV, IR, GC. - Preparing and reviewing analytical documents, SOPs, COAs, and test reports. - Ensuring compliance with GMP, GLP, and data integrity requirements. - Maintaining lab documentation following ALCOA+ principles. - Handling OOS, OOT, deviations, and supporting investigations. - Participating in internal and external audits to ensure audit readiness. - Maintaining good housekeeping, safety standards, and adherence to laboratory practices. - Coordinating with cross-functional teams to ensure timely release of batches and samples. This role requires a candidate who is detail-oriented, proactive, and has a strong technical background in analytical instruments and compliance standards. As a Technical Expertise professional, you will be required to have hands-on experience with analytical instruments such as HPLC, UV, IR, and GC. It is essential to have a strong understanding of GMP compliance and adhere to Data Integrity principles like ALCOA/ALCOA+. In your role, you will face audits from regulatory bodies like USFDA, MHRA, WHO, GMP, and ISO. Your responsibilities will include supporting audit preparedness, documentation, and implementing CAPA. Your key responsibilities will involve: - Performing routine and non-routine analysis of raw materials, in-process samples, finished products, and stability samples. - Operating, calibrating, and troubleshooting analytical instruments like HPLC, UV, IR, GC. - Preparing and reviewing analytical documents, SOPs, COAs, and test reports. - Ensuring compliance with GMP, GLP, and data integrity requirements. - Maintaining lab documentation following ALCOA+ principles. - Handling OOS, OOT, deviations, and supporting investigations. - Participating in internal and external audits to ensure audit readiness. - Maintaining good housekeeping, safety standards, and adherence to laboratory practices. - Coordinating with cross-functional teams to ensure timely release of batches and samples. This role requires a candidate who is detail-oriented, proactive, and has a strong technical background in analytical instruments and compliance standards.