13 Gxp Regulations Jobs

By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description: The Future Begins Here: At Takeda, we are leading digital evolution and global transformation. By building innovative solutions and future-ready capabilities, we are meeting the need of patients, our people, and the planet. Bengaluru, the city, which is India's epicenter of Innovation, has been selected to be home to Takeda's recently...

Hi, We are having an opening for IT Service Assurance Manager at our Mumbai location. Job Summary : We are seeking a seasoned and proactive IT Service Assurance Manager to oversee and optimize the delivery of IT services in a highly regulated pharmaceutical environment. This role is pivotal in ensuring IT services align with business needs, comply with GxP (Good Practice) regulations, and support the organizations mission to deliver high-quality healthcare solutions. The ideal candidate will have a strong background in IT service management, preferred experience in the pharmaceutical or life sciences sector. Areas Of Responsibility : Overseeing global IT service delivery across all Sun Pharm...

Summary The Quality Lead Data & Digital TRD QA is responsible for overseeing, driving and implementing global data & digital (DDI) projects and initiatives within Technical Research and Development (TRD) Quality Assurance (QA). This role collaborates closely with relevant partners in TRD, Research & Development Quality (RDQ) and Operations Quality and leads the TRD QA DDI Network. The role incumbent ensures all DDI projects and related business processes are well supported by TRD QA and covered by change control as applicable. The role owner also drives digitalization and artificial intelligence (AI) solutions within TRD QA and is the Go to person for related topics within this organization....

As the Quality Lead Data & Digital TRD QA at Novartis, you will be responsible for overseeing, driving, and implementing global data & digital projects within Technical Research and Development Quality Assurance. Your role will involve collaborating closely with relevant partners in TRD, Research & Development Quality, and Operations Quality, leading the TRD QA DDI Network, and ensuring all DDI projects and business processes are well supported and covered by change control. **Key Responsibilities:** - Lead the global TRD QA DDI Network with a team of direct and/or indirect reports - Ensure DDI projects impacting TRD are well supported and covered by change control - Drive the TRD QA DDI age...

As a Quality Systems Lead at BioBioPharma Tech Solutions, you will be responsible for managing Veeva Vault Workstreams on a global level. Your role will involve providing project management leadership for Veeva QMS Workstreams, creating reports, monitoring system compliance, owning governing procedures, and supporting validation and configuration activities. You will also be responsible for providing guidance and support for site requests, issue resolution, and regulatory inspection requests. Key Responsibilities: - Provide project management leadership for Veeva QMS Workstreams including Quality Docs, Vault Training, QMS, Validation, etc - Create reports, monitor and maintain system complia...

The Digital Risk & Compliance Expert Controls Assurance will be responsible for driving the execution of assessment and testing campaigns such as GxP Periodic Reviews & Third Party Assessments within the Digital Risk & Compliance team. Your impact will extend beyond the team as you support the Digital transformation objective of halving the time from discovery to therapy by ensuring Risk & Compliance at the speed of the business. In this role, you will have the opportunity to work in an international environment as part of a dynamic team, empowered to propose and implement innovative ideas. You will collaborate with diverse business teams and vendors, gaining hands-on experience and contribu...

ZS is a place where passion changes lives. As a management consulting and technology firm focused on improving life and how we live it, we transform ideas into impact by bringing together data, science, technology and human ingenuity to deliver better outcomes for all. Here you'll work side-by-side with a powerful collective of thinkers and experts shaping life-changing solutions for patients, caregivers and consumers, worldwide. ZSers drive impact by bringing a client-first mentality to each and every engagement. We partner collaboratively with our clients to develop custom solutions and technology products that create value and deliver company results across critical areas of their busines...

The MES Lifecycle Manager role at Sanofi is integral to the company's digital transformation and standardization efforts within Manufacturing & Supply. You will be responsible for overseeing the lifecycle management of MES systems, including MARS implementations across multiple production sites globally. Your main focus will be on strategic planning and execution of MES installations, updates, and migrations to optimize performance, reduce obsolescence, and align capabilities with digital transformation goals. Your key responsibilities will include developing and executing a comprehensive MES lifecycle planning strategy, orchestrating high-level planning of MES initiatives across industrial ...

You should have a minimum of 5+ years of ETL testing experience with expertise in ETL test planning, functional testing, performance testing, developer management, and defect management using Application Lifecycle Management (ALM) tools. Your experience should include ETL testing with tools such as Informatica, SSIS, Power BI, and Snowflake. Additionally, you should have proficiency in test data management, processes analysis, and documentation using industry standard tools. It is essential to have experience working with scrum/agile or other project management methodologies. Knowledge or experience in the life sciences/biotech space is preferred. Strong written and verbal communication skil...

You will be responsible for overseeing and coordinating the Quality Assurance (QA) program to support customer accounts, operational teams, audit and inspection programs, and the quality management system (QMS) for the Digital Products and Solutions (DP&S) organization. Your role will involve providing guidance, interpretation, support, and training to delivery and development groups on regulations, guidelines, corporate standards, and policies. You will also be involved in documentation, reporting, investigation, and closure of compliance issues such as deviations, quality issues, CAPAs, and audit findings. Additionally, you will organize and deliver training to other departments on Quality...

In this vital role, you will facilitate Scrum events and processes for the Regulatory Structured Submissions Team. Your responsibilities include enhancing team communication and collaboration, ensuring alignment with program goals, managing risks and dependencies, and driving continuous improvement. The Scrum Master adapts and refines SAFe principles to suit organizational needs, standardizing and documenting practices. Lead and handle product delivery using agile frameworks and techniques, aligning with Agile values such as prioritizing individuals and interactions over processes and tools for Veeva Vault systems Team. Capture the voice of the customer to define business processes and produ...

As an experienced professional with over 3 years of experience in Computer System Validation (CSV) and IT quality assurance within regulated industries such as pharmaceuticals, biotechnology, or medical devices, you will be responsible for developing, executing, and documenting CSV protocols and reports for both new and existing computer systems and software applications. Conducting risk assessments and gap analyses will be a key part of your role to identify potential quality issues and implement necessary corrective actions. Your responsibilities will also include developing and maintaining quality documentation, such as Standard Operating Procedures (SOPs), validation plans, test cases, a...

As an experienced professional with over 3 years of experience in Computer Systems Validation (CSV) and IT quality assurance within regulated industries such as pharmaceuticals, biotechnology, and medical devices, you will be responsible for the following key tasks: - Developing, executing, and documenting CSV protocols and reports for both new and existing computer systems and software applications. - Conducting risk assessments and gap analyses to identify potential quality issues and implementing corrective actions as necessary. - Developing and maintaining quality documentation including Standard Operating Procedures (SOPs), validation plans, test cases, and reports. - Participating in t...