Must have experience with ISO 17025 for Food & Water Testing, including handling of incubator, autoclave, biosafety cabinet, colony counter, Laminar Air Flow, and pH meter.
M.Pharm, B.Pharm, M.Sc ; Exposure to method validation, method transfer on various QC instruments LCMS, HPLC, GC, Dissolution, Malvern 3000 etc. Familiarity with protocol, report preparation.
Liaise and influence the cross functional team to drive the site investigations to meet the supply reliability. Demonstrate the agility and lead the site investigation team to achieve the key quality and supply metrics. Championing in effective implementation of global investigations requirements at site.
To be responsible for Receipt, verification, storage and issuance of laboratory chemicals and glassware. To be responsible for Preparations of volumetric solutions, test solutions, limit test solutions and indicator solutions.
This non-supervisory role in the Reference Standard Laboratory involves performing necessary project tests and maintaining a GLP-compliant environment. The incumbent leverages their technical expertise and pharmaceutical analysis knowledge to conduct collaborative testing and ensure efficient and effective laboratory operations.
Candidate acquainted of Quality Management System Document like Change control, Deviation and their Investigations, CAPA and Audit Management. This role will focus on ensuring the highest standards of quality throughout the manufacturing process, specifically for active pharmaceutical ingredients
Monitoring for Documents compilation activities for New product filing , Re-Registration, renewals from plant dossier filing , sample requirements etc. Participation in Action plan discussion for queries from different Regulatory agencies and monitoring for submission of data/documents from plant.
Performing post-submission processing activities such as receiving acknowledgment from authority of submission receipt; capturing and the electronic receipt and metadata in RIM; communicating submission receipt to key stakeholders