4 Validation Plan Jobs

Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries PQE Group has been at the forefront of these industries since 1998, with 40 subsidiaries and more than 2000 employees in Europe, Asia, and the Americas. Following a new opportunity, we are currently looking for a Junior Consultant: Qualification & Validation (CQV) to join our team in an onsite project at Rupnagar (Chandigarh) Location. The ideal candidate should have 2+ years of experience in a similar role and be able to review and update P&ID, prepare Qualification Documents like Validation Plan, Design Qualification, User requirement specification, Installation Qualification, Operational Qualification, Performance Qualification, System impact assessment, Functional Risk Assessment, Qualification summary report, Standard Operating Procedure (SOP), Change Control, and drafting DCS-PLC Process write up. The candidate should also be willing to travel and relocate as per project requirements anywhere in India and global locations after the project completion. An immediate joiner is required (20 Days). Location: Rupnagar (Ropar) - Punjab, near Chandigarh. As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation. PQE Group offers you the opportunity to work on international projects, enhance your skills, and engage with colleagues from around the world. If you are seeking a rewarding and exciting career, PQE Group is the perfect place for you. Apply now and take the first step towards an amazing future with us.,

As the Platform Team Lead for Vehicle Design & Integration (Premium Motorcycles) at Hero Motocorp, you will be responsible for leading the design & integration team for VED systems for the GB premium/high performance motorcycle platforms under your supervision. This includes overseeing the Structures, Wheel, Brakes, and Suspension systems, as well as ensuring the Vehicle Integration of all systems/components on the motorcycle. Your role will involve identifying critical-to-quality parameters, detailing the design & release of all VED systems for the project, and developing a validation plan to meet customer expectations. Additionally, you will need to understand the various use cases and loading conditions during vehicle running & handling and translate them into a validation specification. It is crucial for you to be an expert in understanding and maintaining HMCL stage gate requirements, regulatory standards, and safety compliance. You will also be expected to create and update standard R&D documentation such as Design Guidelines (HEG), DFMEA, and problem-solving tools. Your day-to-day responsibilities will include ensuring the delivery of VED project deliverables within set CTQ Parameters, providing VED technical leadership for the platforms within the entire HMCL organization, managing the VED Platform team to achieve maximum NPD efficiency, conducting system layout & design reviews, offering technical guidance for VED work from a vehicle platform perspective, and working towards ensuring the smooth implementation of LEAP/LEAD/MP activities. To be eligible for this role, you should have a BE/ BTech in Mechanical/Automotive Engineering from a renowned institute. Your technical skills should encompass project management, people management, communication & influencing skills, understanding of DFMEA, DFM / DFA / DFS and GD&T, knowledge of vehicle systems such as structures, Suspension, Brakes, Wheels, and Vehicle Integration, innovation capabilities, FEA analysis proficiency, test and validation planning expertise, and understanding of Layout/vehicle dynamics of motorcycles. Additionally, having experience in handling suppliers and internal/external customers, along with a passion for motorcycling and automotive engineering, would be advantageous. Working at Hero Motocorp, the world's largest manufacturer of motorcycles and scooters for the last 22 years, will provide you with the opportunity to collaborate with bright innovators dedicated to excellence. You will be part of India's esteemed legacy, contributing to a brand celebrated by 110 million Indians and expanding its global presence as a manufacturing powerhouse. If you are someone who aspires to achieve big dreams with unwavering conviction, Hero Motocorp is the ideal workplace for you. Join us in shaping the future of mobility, driving innovation, and striving for the best in the industry. Hero MotoCorp, headquartered in New Delhi, is a global leader in manufacturing motorcycles and scooters, with a presence in 47 countries across Asia, Africa, Latin America, and the Middle East. Committed to developing modern, technologically advanced, and eco-friendly mobility solutions, Hero MotoCorp aims to achieve its next 100 million sales by 2030. With a focus on sustainability, innovation, and global expansion, Hero MotoCorp offers a dynamic work environment where you can unleash your full potential and be part of a pioneering team driving positive change in the world of transportation.,

Job Description: A day in the life of an Infoscion As part of the Infosys consulting team your primary role would be to actively aid the consulting team in different phases of the project including problem definition effort estimation diagnosis solution generation and design and deployment You will explore the alternatives to the recommended solutions based on research that includes literature surveys information available in public domains vendor evaluation information etc and build POCs You will create requirement specifications from the business needs define the to be processes and detailed functional designs based on requirements You will support configuring solution requirements on the products understand if any issues diagnose the root cause of such issues seek clarifications and then identify and shortlist solution alternatives You will also contribute to unit level and organizational initiatives with an objective of providing high quality value adding solutions to customers If you think you fit right in to help our clients navigate their next in their digital transformation journey this is the place for you Key Responsibilities: Key components of the responsibilities are as mentioned below but not limited to 6 yrs of Professional experience and strong knowledge with real time experience in IT Quality Compliance Computer System Validation Software Testing System Implementation in the Life Sciences industry Leads the effort to manage and or maintains validation of the GxP computerized systems Create Validation Plan Validation Report and Reviews validation documents such as URS FS FRA DD IQ OQ PQ s TRM Assure compliance with GxP GMP GCP GLP privacy requirements Develops and maintains IT GxP compliance documentation Ensure GxP Computerized Systems are validated as per GAMP 5 requirements Stakeholder management and good executor with required communication Candidate must have fair conceptual understanding on below key areas o IT QMS o Validation Qualification o Risk management o Handling of defects Deviations o Investigations o CAPA Handling o Test Management Compliance Candidate must have understating on latest regulations i e 21CFR Part 11 EU annex 11 and Guidelines e g GAMP5 guide Candidate will provide an application validation expertise practically on different scenarios as applicable case to case i e standalone enterprise etc Technical Requirements: Hands on experience on testing tools like HP ALM Kneat and SNOW Experience to MES QMS Trackwise Lab solutions i e LIMS Empower CDS Chromeleon Business Analytics Middle wares etc will be an advantage OT System Qualification Radio ligand Therapy or critical dosage forms will be a plus PAS DCS Qualification ISA95 High level of understanding OT Security will be a plus Standalone Systems Qualifications PAS DCS Integrated with Manufacturing Equipment qualification Preferred Skills: LS Domain->Computer System Validation (CSV)

Roles and Responsibilities Conduct CSV activities such as risk assessment, gap analysis, and validation planning. Perform computer system validation (CSV) activities according to industry standards like GAMP5 and 21 CFR Part 11. Ensure compliance with EU Annexure 11 requirements for software validation. Collaborate with cross-functional teams to identify and resolve issues related to HPLC, LIMS, EMS, BMS systems. Develop test scripts and execute tests using V-model approach. Preparation, Execution, Compilation and approval of below documents (Not limited to) 1) User requirement specifications 2) Validation Plan 3) GxP Assessment 4) System Design Specification 5) Risk Assessment 6) Network (Infra) Qualification 7) Installation Qualification protocol 8) Operational Qualification 9) Performance Qualification 10) Traceability matrix 11) Validation summary report