4 Job openings found

Job Description: We are seeking a dedicated QMS professional to oversee and maintain the Quality Management System in compliance with cGMP and regulatory requirements. The role involves managing documentation, handling quality events, and supporting internal and external audits in an API manufacturing environment. Key Responsibilities: Implement and maintain QMS processes in line with ...

Key Responsibilities: 1. Method Development & Validation Develop analytical methods for assay, dissolution, related substances, and stability testing. Conduct method validation as per ICH guidelines (accuracy, precision, specificity, linearity, robustness). Optimize and troubleshoot existing analytical methods. 2. Instrument Handling Operate analytical instruments such as HPLC, GC, UV, FTIR, KF, Dissolution Apparatus, etc. Perform daily calibration and ensure ...

Key Responsibilities: Analytical Operations: Perform routine and non-routine analysis using HPLC, GC, UV and other instruments. Conduct and support analytical method validations as per regulatory requirements. Review and approve analytical data, test reports, and batch release documents. Ensure proper calibration and qualification of laboratory instruments. QMS & Compliance: Manage Quality Management System (QMS) activities including:OOS, Deviations, CAPA, ...

Responsibilities Perform and supervise In-Process Quality Assurance (IPQA) OR QA checks during API manufacturing operations. Conduct on-line review of Batch Production Records (BPR) and ensure adherence to approved procedures. Ensure sampling, line clearance, and process compliance as per GMP/cGMP norms. Identify, record, and support resolution of deviations, non-conformances, and quality incidents during manufacturing. Support quality investigations and prepare required ...