Description

- Supervising and coordinating the activities of QC analysts and ensuring optimal utilization of laboratory resources.
- Reviewing and approving quality control documents, including analytical data, laboratory records, stability studies, investigations, protocols, reports, and certificates.
- Ensuring laboratory compliance with cGMP, data integrity requirements, SOPs, safety guidelines, and regulatory expectations during routine operations.
- Leading and participating in laboratory investigations related to OOS, OOT, deviations, atypical results, and laboratory incidents, including root cause analysis and implementation of CAPAs.
- Preparing, reviewing, revising, and maintaining Standard Operating Procedures (SOPs) and other controlled quality documents.
- Reviewing, preparing, and updating specifications (SPECs), Standard Test Procedures (STPs), analytical methods, protocols, and related quality system documents.




- Providing technical guidance and troubleshooting support for chromatographic and laboratory-related issues.
- Planning and conducting training programs to enhance personnel competency and ensure compliance with current procedures and regulatory requirements.
- Monitoring analyst qualifications, training effectiveness, and periodic evaluations.
- Coordinating instrument qualification, calibration, maintenance activities, and ensuring laboratory equipment remains in a compliant state.
- Supporting method validation, method transfer, verification, and stability studies as per regulatory requirements.
- Collaborating with cross-functional departments including QA, Manufacturing, Regulatory Affairs, and R&D; to support product quality and compliance objectives.
- Driving continuous improvement initiatives aimed at improving laboratory efficiency, compliance, and operational excellence.

To take up by the additional activities

📌 Assistant manager, Quality control (India)
🏢 Par Formulations
📍 India