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5.0 - 9.0 years
0 Lacs
Hyderabad, Telangana, India
Remote
Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more careers.bms.com/working-with-us . Key Responsibilities Functional and Technical Participate in CSV activities for applications across multiple GxP business areas to ensure 'fit for use' before release to production environment Participate in Qualification activities as it relates to infrastructure applications and hardware in a timely manner Be part of the team that Conducts risk & impact assessments to determine the extent of validation and qualification requirements Implementation of organizational IT controls in accordance with applicable regulations and internal procedures Author CSV deliverables including but not limited to Plans & Summary Reports Support the SLC process as it relates to application validation and infrastructure qualification Identifies opportunities for simplification, automation for CSV activities and partners with IT Delivery teams and IT Quality to implement Supports inspections and audits (internal and external ). Conducts periodic reviews to ensure applications remain in a state of compliance Participates and represents IT Validation Services in problem management and audit remediation activities Provides regular status updates to one up manager and escalates any potential issues in a timely manner People Management Support CSV staff across defined GxP business unit applications to ensure 'fit for use' before release to production environment Qualifications & Experience B.E./B.Tech. or equivalent in computer science, engineering, life science field A minimum of 5-9 years of experience in computer systems validation in the pharmaceutical industry, including at least 3 years managing CSV projects Experience validating one or more of the following systems (desirable) CTMS, eTMF, ServiceNow, Veeva, Qumas, SAP, MES, PV, eDC, Regulatory Submission systems General knowledge of IT applications, IT infrastructure, architecture of computer systems including cloud as well as networks, operating systems, databases, and software tools Good knowledge (mandatory) of IT testing practices and methodologies in the Pharma GxP space-and good working knowledge of test management tools like ALM etc. Familiarity with test automation tools desirable Good understanding (mandatory) of Electronic Records and Electronic Signature regulations, Data Integrity principles and GAMP methodology Works predominately within established procedures. Ability to make decisions that impact own work and other groups/teams and works under minimal supervision Demonstrates openness to learning and developing. Takes a responsibility for their own development and growth Excellent English verbal and written communication skills including the ability to write clear and precise documentation and deliver articulate presentations If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information https //careers.bms.com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Posted 2 weeks ago
5.0 - 9.0 years
0 Lacs
Hyderābād
Remote
Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us . Key Responsibilities Functional and Technical Participate in CSV activities for applications across multiple GxP business areas to ensure 'fit for use' before release to production environment Participate in Qualification activities as it relates to infrastructure applications and hardware in a timely manner Be part of the team that Conducts risk & impact assessments to determine the extent of validation and qualification requirements Implementation of organizational IT controls in accordance with applicable regulations and internal procedures Author CSV deliverables including but not limited to Plans & Summary Reports Support the SLC process as it relates to application validation and infrastructure qualification Identifies opportunities for simplification, automation for CSV activities and partners with IT Delivery teams and IT Quality to implement Supports inspections and audits (internal and external ). Conducts periodic reviews to ensure applications remain in a state of compliance Participates and represents IT Validation Services in problem management and audit remediation activities Provides regular status updates to one up manager and escalates any potential issues in a timely manner People Management: Support CSV staff across defined GxP business unit applications to ensure 'fit for use' before release to production environment Qualifications & Experience B.E./B.Tech. or equivalent in computer science, engineering, life science field A minimum of 5-9 years of experience in computer systems validation in the pharmaceutical industry, including at least 3 years managing CSV projects Experience validating one or more of the following systems (desirable): CTMS, eTMF, ServiceNow, Veeva, Qumas, SAP, MES, PV, eDC, Regulatory Submission systems General knowledge of IT applications, IT infrastructure, architecture of computer systems including cloud as well as networks, operating systems, databases, and software tools Good knowledge (mandatory) of IT testing practices and methodologies in the Pharma GxP space-and good working knowledge of test management tools like ALM etc. Familiarity with test automation tools desirable Good understanding (mandatory) of Electronic Records and Electronic Signature regulations, Data Integrity principles and GAMP methodology Works predominately within established procedures. Ability to make decisions that impact own work and other groups/teams and works under minimal supervision Demonstrates openness to learning and developing. Takes a responsibility for their own development and growth Excellent English verbal and written communication skills including the ability to write clear and precise documentation and deliver articulate presentations If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Posted 2 weeks ago
1.0 years
0 Lacs
Bengaluru, Karnataka, India
On-site
BIOVIA User Success Engineer As a BIOVIA User Success Engineer, you offer exceptional, high-quality technical assistance to DASSAULT SYSTEMES valued Customers, going above and beyond standard support to ensure their needs are met with highly technical expertise, effectively treating them with the utmost respect and prioritizing their requirements Role Description: A thorough understanding of the product, allowing for accurate troubleshooting and solutions Troubleshoot and resolve customers reported issues with complete ownership and dedication Anticipating potential problems and offering preventive solutions Submit and track issue with Development Team and validate Solutions provided by Development team Implement the functionality under R&D Guidance for specific customer demand. Work closely with customers and partners as situation demands to resolve issues and ensure smooth deployment/production run Timely deliver answers /solutions including validating all code corrections against customer scenarios Participate in customer calls, on demand, to convey technical expertise and deliver enhanced value & satisfaction Collaborate with Development team to identify the root cause of the issue and deliver the solution. Collaborate with Customer Success Advocate to prioritize the resolution plan Qualifications: A Bachelor’s degree or higher degree in Information Technology, Mechanical Engineering, Computer Science or a Life Sciences related domain 1-3+ years of prior experience in laboratory informatics software. E.g., BOVIA OneLab, QUMAS application. Required Skills Experience in BIOVIA product, life science industry, or chemistry/biology laboratory domain Experience in SQL script creation and Oracle Database administration Experience in Microsoft Windows Server system administration and Active Directory Experience in Web server and networking technologies, such as Apache Tomcat or Microsoft IIS with SSL/TLS certificates TCP/IP and network topology knowledge, including load balancers, routers, etc. Excellent analytical and problem-solving skills Excellent verbal and written communication skills in English Ability to work effectively both independently and as part of a diverse team environment. Ability to adapt to changing technologies and learn new skills quickly. What’s in it for you: As a member of Customer Success Organization, you will be the representative of DASSAULT SYSTEMES to our esteem customers worldwide, helping them to resolve their issues. As a member of Customer Success Organization, you will collaborate with a diverse, distributed group of multi-disciplinary teams to provide technical support to the worldwide customers of DASSAULT SYSTEMES Inclusion statement As a game-changer in sustainable technology and innovation, Dassault Systèmes is striving to build more inclusive and diverse teams across the globe. We believe that our people are our number one asset and we want all employees to feel empowered to bring their whole selves to work every day. It is our goal that our people feel a sense of pride and a passion for belonging. As a company leading change, it’s our responsibility to foster opportunities for all people to participate in a harmonized Workforce of the Future. Show more Show less
Posted 1 month ago
10.0 years
0 Lacs
Mumbai Metropolitan Region
Remote
Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, we surpassed $2B in revenue in our last fiscal year with extensive growth potential ahead. At the heart of Veeva are our values: Do the Right Thing, Customer Success, Employee Success, and Speed. We're not just any public company – we made history in 2021 by becoming a public benefit corporation (PBC), legally bound to balancing the interests of customers, employees, society, and investors. As a Work Anywhere company, we support your flexibility to work from home or in the office, so you can thrive in your ideal environment. Join us in transforming the life sciences industry, committed to making a positive impact on its customers, employees, and communities. The Role Veeva’s Vault Quality platform will truly change how the industry manages Quality, and we want you on our team! Veeva Systems is looking for a Project Manager who has a deep customer focus and a passion for helping customers transform the way they manage their Quality data and content within our product. This is an expert-level role that requires strong Quality domain experience, customer-focused project management, and problem-solving skills as you lead and manage large-scale global enterprise cloud software projects for Veeva. Ability to drive governance at all levels and lead a consulting team in an enterprise implementation project. We are looking for individuals with exceptional abilities in the delivery of large cloud transformation programs across the enterprise and client relationship management, and leadership skills to manage a team to grow and thrive in an environment with professional agility. If you excel in building productive relationships, aligning strategies, and excelling in a dynamic environment, then this could be an excellent match for you. Candidates must be based in Mumbai, India, or willing to relocate. What You'll Do Participate in projects at life sciences companies designing and deploying Quality systems Collaborate with the client’s leadership and other Project Managers to establish and execute a sound project management methodology for delivering Services related to the implementation of the Vault Quality suite Provide oversight for Services projects and deliver agreed services on time and with high customer satisfaction Establish close, collaborative relationships with customer stakeholders to understand and act on customer needs Drive governance and demonstrate leadership by working across customer and internal teams to support all phases and workstreams within the implementation of the Vault Quality suite of applications Manage day-to-day project activities and project administration Enable your project team to focus on solution design, prototyping, configuration, training, and documentation Mentor project team members in the Services organization and identify growth opportunities Proactively manage risk, anticipate potential problems, and identify mitigation strategies Be transparent in all communications and reflective in conducting post-project assessments — identify learnings that will help improve the overall process Establish and provide regular reporting on project status, key metrics, and deliverables, and customize to address key stakeholder groups Requirements 10+ years of direct experience leading teams working with GXP Quality software solutions across QMS, DMS, LMS, LIMS, Validation Lifecycle Management, and/or delivering project management for related services in a Life sciences organization Experience in reporting to senior/executive-level stakeholders and technology teams with superior communication skills Exceptional project management skills with the ability to prioritize and manage multiple projects in a cross-functional environment that values speed Experience working with different LMS platforms such as SuccessFactors, Compliance Wire, and Vault Training The position requires a level of confidence to hold the line with customers and internal teams and be an advocate for the project Proven track record of meeting project timelines/deliverables and attention to detail, process, deadlines, and quality results Ability to travel up to 20% Nice to Have Understanding of global quality requirements, compliance considerations, and processes for Quality, Content Management, life sciences GxP training compliance, as well as QC LIMS and/or Validation Experience implementing Document or Quality Management systems for life sciences as a consultant, business, or IT representative Direct experience with systems such as Veeva Vault Quality, Honeywell Sparta TrackWise, OpenText, Documentum D2, Biovia QUMAS, UL Compliance Wire, and SAP Success Factors Consulting experience Life Science, computer science, biochemical, and mechanical engineering or related degree SaaS/Cloud experience Perks & Benefits Allocations for continuous learning & development Health & wellness programs Flexible PTO Veeva’s headquarters is located in the San Francisco Bay Area with offices in more than 15 countries around the world. Veeva is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin or ancestry, age, disability, marital status, pregnancy, protected veteran status, protected genetic information, political affiliation, or any other characteristics protected by local laws, regulations, or ordinances. Show more Show less
Posted 1 month ago
0 years
0 Lacs
Pune, Maharashtra, India
On-site
Responsibilities: a) Provide L1 & L2 technical support for QUMAS users, resolving system issues, access problems, and workflow errors. b) Troubleshoot performance issues, integration errors, and system security vulnerabilities related to QUMAS. c) Work with IT teams to resolve server, database, and network-related issues affecting QUMAS functionality. d) Monitor QUMAS performance, uptime, and security to ensure system reliability. e) Perform software updates, patches, and system configurations as needed. f) Manage user accounts, roles, and access permissions following security and compliance guidelines. g) Monitor electronic signatures, audit trails, and data integrity within the QMS platform. h) Address user inquiries, service requests, and tickets through IT helpdesk systems i) Collaborate with vendors and developers to resolve system bugs and enhance functionalities. Experience: a) Proven experience working with QUMAS or other quality management systems (e.g., MasterControl, Veeva Vault QMS), QUMAS DocCompliance, ProcessCompliance, and Training modules. b) Previous experience in a GxP-compliant environment is highly preferred. c) Experience with document processes, workflows, and standard operating procedures (SOPs) within the QMS platform. d) Experience with generating and analysing reports related to quality management performance, system usage, and compliance status. Skills: a) Strong understanding of document control, regulatory compliance, CAPA, risk management, and workflow automation. b) Experience with SQL databases, Windows/Linux servers, and enterprise system integrations. c) Basic scripting knowledge (PowerShell, Python) is a plus. b) Familiarity with document management systems (DMS) and quality management software. c) Excellent problem-solving skills and ability to troubleshoot technical issues. d) Strong communication and training skills. e) Ability to work both independently and collaboratively with cross-functional teams. Show more Show less
Posted 2 months ago
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