It Validation Jobs – Apply to Latest It Validation Job Vacancies

Sr. Engineer/ Pro. Engineer/Asst. Manager - Security Audit Foxconn

6.0 - 11.0 years

5 - 13 Lacs

Chennai

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We are seeking a skilled Security Audit professional with experience in the Manufacturing or Electronics Manufacturing industry. Candidates from the IT industry will not be considered. The role focuses on conducting thorough security audits, managing inventory controls, and ensuring compliance with device and material handling policies within a manufacturing setup. Key Responsibilities: Manage NPI (New Product Introduction) area segregation and conduct NPI perimeter audits to ensure strict access control. Audit various types of raw materials, verify critical material storage requirements, maintain critical material inventory audits, and track material movement accurately. Implement and monitor personal screening procedures and ensure equipment calibration standards are met. Oversee device control policy enforcement, conduct device inventory audits, validate IT approvals, and maintain detailed device control logs. Conduct material inventory control and perform regular audits to ensure compliance. Maintain track and trace (TT) control data for materials and devices. Provide TT training to cross-functional teams (CFT) and security teams, and support the implementation of related processes. Support application development, coordinate with IT teams, assist cross-functional teams, and handle escalation management. Required Profile: 6 to 13 years of relevant experience in security audits or material control within Manufacturing or Electronics Manufacturing industries. Strong knowledge of NPI processes, material storage protocols, device control, and inventory audit practices. Experience in conducting audits, maintaining control data, and enforcing compliance standards. Ability to train and guide cross-functional teams on security audit processes. Good coordination skills with IT and other support teams. Detail-oriented, with excellent documentation and communication skills. Note: Candidates with experience primarily in the IT industry will not be considered. If you have the required background and are looking to grow your career in Security Audit within a manufacturing environment, we encourage you to apply.

Posted 2 weeks ago

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Senior IT Validation & Compliance Specialist I Novo Nordisk

7 - 12 years

9 - 14 Lacs

Bengaluru

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The position As a Senior IT Validation and Compliance Specialist I at Novo Nordisk, you will have the following responsibilities: Define and execute validation and qualification strategies for GxP Computerized Systems, Computerized Equipment, Infrastructure, or Robotic Process Automation (RPA) and Emerging Tech such as Artificial Intelligence (AI) and Machine Learning (ML). Develop validation plans, validation reports, design reviews, test strategies, and execute validation activities. Ensure systems are in compliance with relevant internal and external regulatory requirements. Participate in audits and inspections, identifying and implementing solutions to compliance gaps. Provide compliance consulting for IT projects and deliver compliance deliverables related to Computer System Validation (CSV). Manage multiple concurrent tasks and be flexible in handling complex projects. Mentor and guide junior colleagues in validation activities. Qualifications To be successful in this role, you should have the following qualifications: You hold Bachelors or Masters in relevant field with minimum 10+ years of experience in working in a service -based organization/pharmaceutical industry preferably in the IT quality domain and preferred to have Industry recognized ITIL and ISO quality management certification. You should have minimum 7+ years of practical experience in GxP areas with exposure to regulatory affairs, 7+ years in performing Root Cause Analysis (RCAs), 2+ years in service management and any other relevant IT quality activities. Proven management skills in quality as well as validation activities and Global Stakeholder Management in Pharmaceutical field and expertise in SDLC and STLC. Knowledge of and experience with regulatory requirements (e.g. GMP, 21 CFR Part 11), GxP, self-driven to ensure that the IT systems will pass inspections from the authorities without problems. You should have experience in Risk assessment and exposure to Test management tools such as HP ALM. Should be able to effectively manage employee utilization and maximum efficiency with right balance on employee engagement, coach and develop employees. Expert in performing validation?activities for complex projects and ability to represent NN in relations with users and external stakeholders. Strong interpersonal, analytical, communication and collaboration skills and ability to represent NN in relation with users and external stakeholders.

Posted 2 months ago

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Manager IT CSV Domnic Lewis Private Limited

9 - 12 years

27 - 30 Lacs

Mumbai

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Manage Computer System Validation (CSV) activities, ensuring compliance with regulatory standards. Oversee IT validation processes, risk assessments, and audits.

Posted 3 months ago

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