Endo
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Assisting in the preparation and review of PM/CAL/PPV schedules, coordinating instrument calibration and validation activities, reviewing external service reports, and assisting in QMS handling. Troubleshooting issues and technical write-ups are also required skills.
Review and approval of specifications, qualification documents, investigation and review reports, support in change control, computer system validation, audit trail review, and handling of change control and CAPA.
Assist group leader in the day-to-day functioning of the Analytical Research & Development Laboratory. Provide expert input in analysis and characterization of different Injectable formulations. Conduct method transfer and review development reports and protocols.
Manage and coordinate Microbiological testing of raw materials, in-process materials, finished products, and stability samples. Ensure compliance with SOPs and regulatory guidelines. Plan work allocation, troubleshoot lab operations, and collaborate with cross-functional teams. Develop and review SOPs and protocols. Commitment to diversity, equity, and inclusion.
The Field Reimbursement Manager (FRM) is a critical front-line member of the Endo Access and Reimbursement team who represents Endo’s interest with HCP accounts, providing education and assistance related to access of specific products. They work to minimize access and reimbursement barriers for patients and providers within their geography.
Assist in implementing the compliance monitoring program and support the aggregate spend program. Conduct monitoring activities, develop reports, communicate findings, interact with stakeholders, and assist in compliance training and actions.
Responsible for the operation, cleaning, and troubleshooting of packaging lines. Ensure smooth operation and perform preventive maintenance of packing equipment. Execute documentation according to standard operating procedures and regulatory requirements.
Responsible for the operation, cleaning, and troubleshooting of Blister packing, Bottle Packing, and Pouch packing area. Ensures smooth operation and preventive maintenance of equipment. Executes documentation following standard operating procedures and regulatory requirements.
Perform analysis of in-process samples, finished product samples, and other analytical testing based on routine requirements. Maintain lab compliance, documentation, and safety standards. Follow good laboratory and documentation practices. Attend training activities and ensure lab compliance. Initiate change requests and maintain 5S practices in the workplace.
Responsible for ensuring shopfloor compliance and in-process quality assurance activities including line clearance, sampling, quality examination, calibration, and batch records review.
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.