Career CategoryQuality Job Description Position Summary Join Amgen’s mission of serving patients by providing strategic leadership, quality oversight, and global process stewardship for GxP computerized systems, AI-enabled technologies, and emerging digital solutions. The Senior Manager, Global IT Quality,
OVERVIEW: The CSV (Computer Systems Validation) Manager, Trial Interactive leads and advances TransPerfects global Life Sciences compliance initiatives, including 21 CFR Part 11, GCP/ICH requirements, and the companys ISO 9001-certified Quality Management System (QMS). The role holds direct accountability
Location: Remote Experience: 4-8 years Shift timing: 7:30 PM to 4:30 AM IST About the role: We are looking for a skilled Computer System Validation (CSV) Auditor with strong expertise in GAMP 5 Second Edition, FDA Computer Software Assurance
About CAI: CAI was established in 1996; it has grown year over year to more than 750 people worldwide. We provide commissioning, qualification, validation, start-up, project management and consulting services related to operational readiness to FDA regulated
Overview Minimum 7 to 9 years of experience in software testing/validation in a regulated environment. Ability to successfully manage multiple tasks and timelines Ability to effectively liaise with project team members and other teams/departments, on-site and remotely.
Description: Prepare and review qualification protocols and reports for equipment, utilities, and systems (DQ, IQ, OQ, PQ, as applicable). Coordinate and monitor qualification activities with Engineering, Production, and Validation teams. Ensure qualification documentation complies with GMP and regulatory
About the Role: We are seeking a seasoned Computer System Validation (CSV) and Regulatory Compliance Specialist with a strong background in GxP, GAMP 5, and 21 CFR Part 11 to lead and support the validation of our technology platforms,
About ValGenesis ValGenesis is a leading digital validation platform provider for life sciences companies. ValGenesis suite of products are used by 30 of the top 50 global pharmaceutical and biotech companies to achieve digital transformation, total compliance
Summary of Position: We are seeking a Quality Assurance Engineer to provide QA oversight for Digital Health software tools and customer‑facing supporting software systems and infrastructure within a regulated environment. In this role, you will work closely
YASH Technologies is a leading technology integrator specializing in helping clients reimagine operating models, enhance competitiveness, optimize costs, foster exceptional stakeholder experiences, and drive business transformation. At YASH, we’re a cluster of the brightest stars working
, India Job Family Group:Maintenance, Reliability and Turnarounds Worker Type:Regular Posting Start Date:June 30, 2026 Business Unit: Experience Level: Early Careers Job Description: What’s the role You will be part of Technical Asset Support organization in
Duties & Responsibilities Lead, develop, and execute comprehensive Computer System Validation (CSV) strategies, plans, and protocols (IQ/OQ/PQ) in compliance with FDA and global regulatory requirements. Oversee validation activities for GxP-regulated computerized systems including ERP, QMS, MES, manufacturing equipment software, data integrity
Project Role : Business Architect Project Role Description : Identify opportunities to deliver tangible business value by assessing the current state, capturing high-level requirements, and defining business solutions. Translate business needs into technology-enabled solutions and operating
Job Description: Experience required: 10-15 years Project Delivery Manager (Validated Digital Application: MDRIFT) Position Summary We are seeking an experienced Project Delivery Manager to lead the delivery of the validated digital application MDRIFT through multiple enhancement
Role: QA Lead – IT Operations (IT QC SME) Location: Hyderabad Summary The IT QA Subject Matter Expert (SME) will serve as the primary expert and point of contact for quality‑related computerized systems, including Veeva DMS, Veeva QMS,
Career CategoryInformation Systems Job Description Role Name: Principal Information Security Architect - Encryption Agility Team Job Posting Title: Senior Specialist Information Security - Encryption Agility Team Architect Workday Job Title: Senior Specialist Information Security Department Name: Trusted
Job Title- Quality Assurance Specialist Location- Goa Main responsibilities: Management of Quality Systems Compilation, Review & Management of overall Product Quality Reviews system. Act as site coordinator for change controls & management of change control system. Management of Deviation
JLL empowers you to shape a brighter way. Our people at JLL are shaping the future of real estate for a better world by combining world class services, advisory and technology for our clients. We are
The Associate Vice President – Quality Control will provide strategic leadership and operational oversight for the Quality Control function across sterile injectable manufacturing facilities. The incumbent will be responsible for ensuring that all analytical, microbiological, and
Lead and maintain the Pharmaceutical Quality System (PQS) by establishing, implementing, monitoring, and continuously improving quality systems in compliance with ICH Q7, ICH Q9(R1), ICH Q10, applicable cGMP regulations, and company quality policies to ensure a state of