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The Project Management, Senior Manager is responsible for leading project teams and managing cross-functional activities essential for new launches, site transfers, API vendor development programs, and R&D projects. This role involves tracking project progress, identifying risks, resolving difficulties, and ensuring timely project milestones. The role also requires effective collaboration with internal and external stakeholders to achieve project goals and successful product filing.
Manage a team of analysts in QC microbiology laboratory, prepare plans, protocols, reports, and execute day-to-day operations. Commitment to diversity, equity, and inclusion. Cultivate and value each person's unique perspective. Promote a culture of inclusion.
Performing analytical testing, reporting data, method transfer/validation, maintaining records, following safety guidelines, and maintaining lab compliance in a quality control role.
Assistant Manager responsible for handling Cleaning Validation & Verification Activities, reviewing and approving HVAC/LAF/Water System/Manufacturing Equipment's Qualification Protocols, issuing documents, and supporting self-inspection, change control & deviations.
Planning routine analytical activities, logging events and change requests, reviewing documents and analytical data, audit trail review, training and qualification, preparing and reviewing protocols, reports, SOPs, samples, data, and other lab activities as necessary.
Review and assess audit trails of laboratory instruments, prepare/review CSV deliverables, review qualification documents, investigate incidents, and support change control requests. Promote diversity, equity, and inclusion within the team.
Responsible for stability sample analysis and management, as well as monitoring stability chambers. Committed to diversity, equity, and inclusion initiatives at the company.
Responsible for all Engineering activities related to Production, Utility, HVAC, Water system, and other Departments at the Indore SEZ plant. Ensures compliance with organization policies and codes of conduct, prepares SOPs, executes maintenance activities, ensures safety procedures, plans and executes project activities, maintains critical spares, coordinates calibration activities, and manages QMS activities. Collaborates with external vendors and agencies for support as needed. Responsible for all Qualification and Validation activities at the Indore site.
Responsible for instrument breakdown and maintenance, qualification and calibration of instruments/equipment, stock management, coordinating with service engineers, and ensuring compliance with cGMP, GLP, and regulatory requirements.
Perform analysis of in process samples, conduct sampling and testing of cleaning swab samples, ensure timely destruction of samples, execute analysis activities, and prepare documents as required.
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