31 Validation Protocols Jobs - Page 2

Role & responsibilities Develop, execute, and document qualification protocols (DQ/IQ/OQ/PQ) for equipment, utilities, and facilities. Collaborate with Engineering, Production, QA, Or other Cross functional teams to coordinate qualification activities. Maintain qualification documentation, including risk/impact assessments and change-control records. Ensure compliance with USFDA, MHRA, WHOGMP, and ICH Q9/Q10 standards. Support internal and external audits and inspections focused on qualification. Diagnose deviations in qualification processes and initiate CAPAs. Manage and update the Qualification Master Plan and requalification schedules. Specialize in injectable product qualification (medi...

Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company dedicated to developing innovative products that cater to the needs of underserved patients. With a focus on delivering unique, accessible, and high-quality medications, Azurity utilizes its integrated capabilities and extensive partner network to continuously broaden its diverse commercial product portfolio and robust late-stage pipeline. The company's patient-centric products encompass various therapeutic areas such as cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, positively impacting millions of patients. For more information, please visit www.azurity.com. Azurit...

As a Production Manager, you will be responsible for overseeing and managing day-to-day production operations to ensure quality, cost efficiency, and on-time delivery of products. You will develop and implement production schedules while ensuring compliance with Good Manufacturing Practices (GMP) and USFDA regulations. Your role will involve maintaining regulatory compliance with USFDA, WHO, and other standards, coordinating with the Quality Assurance (QA) team for audits, and ensuring proper documentation of manufacturing processes. Leading and mentoring the production team will be a key aspect of your job to drive optimal performance and regulatory awareness. You will be expected to foster...

ABOUT THE ROLE Role Description: We seek a skilled Sr. Associate Validation Analyst to oversee and manage validation activities for AI platforms and solutions. As a key contributor, you will collaborate closely with cross-functional teams to ensure that the AI products follow the required validation processes, documentation, and comply with Amgen s standard operating procedures, policies, and guidelines. Your expertise will be instrumental in ensuring quality and adherence to required standards so that the engineering teams can build and deploy products that are compliant. Roles Responsibilities: Plan, coordinate, and lead the execution of validation and change control activities, including ...

What you will do Role Description: We are seeking a highly skilled Validation Engineer to join our team. You will be responsible for designing, developing, and maintaining software applications and solutions that meet business needs and ensuring the availability and performance of critical systems and applications. This role involves working closely with product managers, designers, and other engineers to create high-quality, scalable software solutions and automating operations, monitoring system health, and responding to incidents to minimize downtime. Roles & Responsibilities: Develop and maintain Validation Plans, including scope, responsibilities, deliverables, and timelines. Perform ri...

Description We are seeking a highly skilled and experienced V&V Vehicle System Test Lead Engineer to join our team in India. In this role, you will be responsible for leading the verification and validation activities for AD/ADAS technologies, ensuring the highest standards of quality and performance in our vehicle systems. Responsibilities Lead the verification and validation (V&V) activities for vehicle systems focusing on Advanced Driver Assistance Systems (ADAS) and Automated Driving (AD). Develop and execute test plans, procedures, and reports for both hardware and software components of vehicle systems. Collaborate with cross-functional teams including software developers, hardware eng...