Lab QA

You will be working as a Senior Executive in the Quality Assurance department at ZLL-SEZ Oncology Injectable (Alidac). Your primary responsibility will involve reviewing Raw Material, Packaging Material, In-process, Finished product, shelf life specification, and relevant Method of analysis. You will authorize the Testing worksheet and approve analytical data of various materials in LIMS. Additionally, you will ensure compliance with Good Laboratory Practices and review analytical method validations, transfers, and verifications. Your role will also include handling, storage, withdrawal, and reconciliation of stability samples, reviewing stability study reports, verifying outside laboratory samples, and ensuring proper documentation of Change Control, Deviation, CAPA, and other quality investigations. You will be responsible for initiating departmental reports, reviewing qualification and calibration documents of QC instruments, and preparing/reviewing stability schedules and reports. Participation in regulatory audits, responding to customer queries, handling Oversight observations, and providing Quality index data will also be part of your duties. You will oversee the calibration, qualification, and maintenance of equipment, review alarm logs and trends, and monitor Critical Quality Attributes. To qualify for this position, you should have a B.Sc./M.Sc./B.Pharm/M.Pharm degree with 5 to 10 years of experience, including at least 2 years at Zydus. Experience in an injectable plant is essential. Your CV can be sent to Garima.G.Jha@ZydusLife.com or HardikA.Bhatt@ZydusLife.com.,