computerized system validation

xperience 5 years of dedicated Computer System Validation (CSV) experience within the pharmaceutical| biotech| or medical device industries.Regulations Deep working knowledge of GxP (GMP| GCP| GLP) environments| 21 CFR Part 11| EU Annex 11| and GAMP 5 principles.Tools Proven experience utilizing Veeva Vault QMS| TrackWise| or highly similar corporate...

We are Generac, a leading energy technology company committed to powering a smarter world.Over the 60 plus years of Generac’s history, we’ve been dedicated to energy innovation. From creating the home standby generator market category, to our current evolution into an energy technology solutions company, we continue to push new boundaries.TBD- see...

ADVANCE YOUR CAREER. ADVANCE THE WORLD. At AMD, we believe technology has the power to solve the world’s most important challenges. From advancing healthcare and scientific discovery to powering AI and the technologies people rely on every day, innovation at AMD is shaping the future. Whether you’re designing next-gen processors, enabling AI...

Company Description SecureGen provides secure computational platforms as a service to support the management of regulatory-compliant data, analysis, and tools for drug development. The company focuses on enabling innovation in life sciences by offering robust, secure, and scalable technology environments. SecureGen’s solutions help research and development...

ADVANCE YOUR CAREER. ADVANCE THE WORLD. At AMD, we believe technology has the power to solve the world’s most important challenges. From advancing healthcare and scientific discovery to powering AI and the technologies people rely on every day, innovation at AMD is shaping the future. Whether you’re designing next-gen processors, enabling AI...

Key Responsibilities * Develop, plan, and execute Design Verification Plans (DVP) for vehicle components and full system validation. * Execute validation testing for electromechanical components, such as electrical ABS assemblies and pressure sensors. * Evaluate validation test results to verify compliance with defined acceptance criteria. *...

We are Generac, a leading energy technology company committed to powering a smarter world. Over the 60 plus years of Generac’s history, we’ve been dedicated to energy innovation. From creating the home standby generator market category, to our current evolution into an energy technology solutions company, we continue to push new boundaries. TBD- see...

At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds. As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life...

Function Quality Pay Band E4 to M2 Role Domain expertise in Wheel, brake, Drive chains, Wheel /Suspension Systems: Design, manufacturing feasibility (casting/forging), and validation of wheel assemblies and interface systems. Design Failure Mode and Effects Analysis (DFMEA) focus for Body/Chassis subsystems. Execute comprehensive checks and failure for...

Designation: Compliance and Validation Specialist Preferred Experience: 3+ Years Job Summary: We are seeking an experienced Compliance Specialist with 5+ years of experience in healthcare, pharmaceuticals, clinical research, or regulated environments. The ideal candidate will be responsible for ensuring organizational compliance with regulatory...

Deliver validation projects successfully across R&D, Clinical, Quality, Regulatory, Digital Transformation, Platform Implementation, and Automation within the GxP environment. Serve clients as a Life Sciences Subject Matter Expert, including Keep up with the latest developments in industry, competition, technology advancements and share through publications...

Role & responsibilities Engineering daily round and document verification in order to compliance. Verification of Calibration planner, preventive maintenance planner to ensure activity done as per scheduled plan. GPS clock time verification across the plant as per schedule, Alarm verification of equipment as per planner. Audit trail verification of...

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 requirements. Maintain qualification...

Responsibilities: Contribute to project’s overall Computer System Validation deliverables. Create and execute test scenarios; select the best testing methodologies, techniques and evaluation criteria for testing.Draft, review and approve validation deliverables such as user requirements, technical design specifications, IQ/OQ/PQ scripts and reports, error...

You will contribute to the success of our clinical programs by analyzing data and implementing validation protocols that support regulatory compliance and data quality What You Will Be Doing Conducting data validation and quality assurance checks to ensure the integrity of clinical trial data Collaborating with cross-functional teams to define validation...

Responsibilities & Key Deliverables The role of Engineer - Build & Validation is a critical position within the Product Development division at Mahindra & Mahindra Ltd, focusing on delivering high-quality tractor systems. The successful candidate will be responsible for comprehensive knowledge and oversight of tractor systems and subsystems, including their...

Job Title: HIL Validation Engineer Location: Chennai, India. Skill set High Voltage Systems, Hardware-In-Loop (HIL) Validation Domain knowledge - Knowledgeable in Battery Management System - Knowledgeable in HV system - Skilled in system Hardware-in-Loop(HIL) Testing - Skilled in HIL report and issue analysis - Skilled in Functional Diagnostic testing and...

Hiring Validation Test Engineer Job Title: Validation Test Engineer Job Type: Full-time Location: Kokapet, Hyderabad (Work from Office only) Experience: 3–5 Years Job Summary We are looking for a detail-oriented Validation Test Engineer with hands-on experience in end-to-end product testing and Computer System Validation (CSV). The candidate will be...

Primary Skills 3-5 years of experience in automotive and infotainment validation Good knowledge and having hands-on experience on domains of Media, Radio, Bluetooth, CCS, Connectivity (Android Auto and CarPlay), Navigation, OTA, Voice recognition Basic knowledge of testing methodologies and defect tracking tools (JIRA) Automotive communication...

Work experience in Biotech / Pharma sector. Knowledge of Equipment qualification and validation. Knowledge of IQ/OQ/PQ documentation. Knowledge of utilities used in pharma sectors. Knowledge of QMS. Knowledge of Computer system validation. Knowledge of Validation master plan Knowledge of Calibration and PM schedule / execution.