141 Gamp Jobs

What you will do In this vital role you will as an Associate System Analyst Veeva Test Engineer at Amgen, you will join the Amgens Veeva Validation Team to help develop test strategies for various Veeva releases in Amgen. You will also assist the operations team in investigating issues with validated Veeva features. Roles & Responsibilities: Develop comprehensive test plans and strategies based on project specifications and requirements. Perform manual and automated testing of software applications, including functional, regression, and performance testing. Document and report defects identified during testing and collaborate with development teams for resolution. Maintain detailed records o...

Roles & Responsibilities Manage and maintain the QMS, ensuring compliance with global medical device regulations. Lead internal and external audits; ensure timely closure of findings. Oversee document control, CAPA, training, and change management processes. Monitor quality metrics and drive continuous improvement initiatives. Support regulatory inspections, product registrations, and management reviews. Collaborate with cross-functional teams to ensure quality integration in all processes. Train and mentor team members on QMS requirements and best practices. Qualifications Bachelor’s/Master’s in Engineering, Mechanical or related field. 7+ years’ experience in Quality Assurance, with 3+ yea...

What you will do: Develop and execute validation strategies and plans for new and existing computerized systems. Create and maintain validation documents including: User Requirements Specifications (URS); Functional Specifications (FS); Risk Assessments; Validation Plans (VP); IQ/OQ/PQ Protocols and Reports; Traceability Matrix Ensure compliance with FDA regulations, EMA guidelines, and GAMP 5 standards. Collaborate with IT, Quality Assurance, Manufacturing, and other stakeholders to ensure system functionality meets business and regulatory needs. Perform impact assessments and change control activities for validated systems. Support data integrity initiatives and ensure systems comply with ...

We are looking for a skilled CSV Lead with 15-25 years of experience to join our team. The ideal candidate will have expertise in ServiceNow and HPALM. Roles and Responsibility Manage and implement CSV solutions using ServiceNow and HPALM. Collaborate with cross-functional teams to ensure seamless integration of CSV with other systems. Develop and maintain documentation for CSV processes and procedures. Troubleshoot and resolve issues related to CSV implementation. Provide training and support to end-users on CSV tools and features. Ensure compliance with industry standards and best practices for CSV management. Job Requirements Strong knowledge of ServiceNow and HPALM. Experience in managin...

Skill: CSV Manager Notice Period: Immediate . Employment Type: Contract Working Mode : Hybrid Job Description 12+ years of experience working in electronic based Computer System Validation in a GxP environment Demonstrated ability to maintain a CSV and Computer and Instrument System Change Control process Experience in employing risk-based approaches to CSV Experience in qualification of GLP Instrument Systems Ability to provide Quality oversight during implementation of GxP Software as a Service tools and systems Experience in perform

About The Role Project Role Software Development Lead Project Role Description Develop and configure software systems either end-to-end or for a specific stage of product lifecycle. Apply knowledge of technologies, applications, methodologies, processes and tools to support a client, project or entity. Must have skills Veeva Vault Good to have skills NA Minimum 5 year(s) of experience is required Educational Qualification 15 years full time education Summary We are seeking a highly experienced and strategic Veeva Vault Clinical Development Lead to manage, lead, and deliver Veeva Vault-based solutions for clinical operations. The ideal candidate will have 5+ years of IT experience with signif...

Educational Requirements Bachelor of Engineering,Master Of Technology,Master of Pharmacy,Bachelor of Pharmacy,Bachelor Of Technology,Bachelor Of Science Service Line Application Development and Maintenance 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...

Educational Requirements Bachelor of Engineering,Master Of Technology,Master of Pharmacy,Bachelor of Pharmacy,Bachelor Of Technology,Bachelor Of Science Service Line Application Development and Maintenance 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...

Requisition Id 1650367 As a global leader in assurance, tax, transaction and advisory services, we hire and develop the most passionate people in their field to help build a better working world. This starts with a culture that believes in giving you the training, opportunities and creative freedom. At EY, we don't just focus on who you are now, but who you can become. We believe that its your career and Its yours to build which means potential here is limitless and we'll provide you with motivating and fulfilling experiences throughout your career to help you on the path to becoming your best professional self. The opportunity Senior Consultant-FS-SaT-SaT - S&E - Corporate Strategy - Mumbai...

The opportunity We have new opportunities for ambitious individuals to join our Tax Team. You will receive extensive training and support from a variety of leading tax professionals to assist you in building a successful career in Tax service line within EY. Your key responsibilities Your client responsibilities Review of tax returns, tax provisions, and work papers. Review of audit of tax deliverables prepared by tax analysts / advanced tax analysts. Act as first level reviewers of products that are finally reviewed by the engagement teams, thus acting in the role equivalent to a counter part in the Ireland. Successfully monitor the engagement team against the plan and budget. Adhere to the...

To review the code for implementing and designing the system/application. Implement new solutions / services as per customer and business requirements. Coordinate with alliance / partnership to generate new / grow revenue. Participate in developing unique IPs, building new services/ solutions to market position and roll out within the unit. Develop sales collateral and marketing materials. Be involved in developing effort estimation & pricing models for productized solution / services. Ensure the sustenance of practices by effective governance. Accountable for accurate budgeting, accounting and billing of engagements. Ensure compliance to internal tools like CDI, Optima as applicable. Identi...

Job summary As a Pharma IT - CSV, you will be responsible for the validation of all GxP-relevant computerized systems used across manufacturing, quality control, and R&D. Your role is critical in ensuring all IT systems meet regulatory requirements from agencies like the US FDA, MHRA, and others. You will manage the entire system validation life cycle, from planning to retirement, within a highly regulated pharmaceutical environment. Responsibilities Validation life cycle: Plan, execute, and document computer system validation activities in accordance with GAMP5 guidelines and internal Standard Operating Procedures (SOPs). Regulatory compliance: Ensure all computerized systems and processes ...

Role Overview: Working at Bristol Myers Squibb is a unique and rewarding experience where you will have the opportunity to engage in meaningful work that impacts the lives of patients worldwide. As a Computer System Validation Lead in the Digital Manufacturing EMES team, you will play a crucial role in ensuring compliance and validation for the Manufacturing Execution System (Syncade) to support BMS" global manufacturing operations. This position offers the chance to work with high-achieving teams and grow through diverse opportunities uncommon in scale and scope. Key Responsibilities: - Develop and implement the test automation strategy, aligning with project goals and timelines. - Design, ...

About the role The SRM will ensure that business stakeholders manage suppliers in line with risk appetite, optimising post-contract value, and developing a transparently sustainable supply base. The role holder will collaborate closely with senior stakeholders from across FIL to establish broad internal stakeholder relationships, drive value from, and manage risk across the supplier portfolio. These stakeholders include but are not limited to: senior executives across FIL; Supplier Relationship Managers (SRMs) across FIL; Supplier Risk Oversight (Procurement 2LoD function); Senior Procurement Category leaders; and risk partners across FIL. The SRM will be use experience of supplier risk and ...

What you will do We are seeking a Business Systems Maintenance Lead to join our digital and sourcing technology team as an Information Systems Manager . This individual will be responsible for managing and coordinating the organizations information systems operations, overseeing deployments, and ensuring continuous improvement of digital tools. The role will require strong technical expertise, project management capabilities, and a passion for driving operational efficiency. This leader will play a critical role in supporting ERP and niche source-to-contract (S2C) systems, maintaining stability and performance, and enabling innovation through special projects such as GenAI implementations. R...

What you will do In this vital role You will play a key role in a content automation initiative which will modernize and digitize the regulatory submission process, positioning Amgen as a leader in regulatory innovation. The initiative demonstrates state-of-the-art technologies, including Generative AI, Structured Content Management, and integrated data to automate the creation, review, and approval of regulatory content. Role Description: We are seeking an Validation Engineer to work on a GxP platform supporting the Regulatory Submission system and Clinical Data Hub platform. This role will be pivotal in ensuring compliance, efficiency, and innovation in the management of data validation pr...

Amgen is seeking a Supplier Onboarding & Vendor Master Senior Associate who will be part of Amgens Global Procure to Pay (P2P) organization. You will be responsible for supporting global supplier enablement activities including supplier on-boarding, vendor master data management, set up and enablement of electronic transacting over shared systems, and catalog management. The Supplier Onboarding Senior Associate role will report to the Supplier Onboarding & Vendor Master Manager. The role will be based in India. Primary responsibilities will include the following: Supplier Onboarding & Vendor Master Management Support business partners on the Supplier On-boarding process, helping resolve issu...

What you will do In this vital role you will as an Associate System Analyst Veeva Test Engineer at Amgen, you will join the Amgens Veeva Validation Team to help develop test strategies for various Veeva releases in Amgen. You will also assist the operations team in investigating issues with validated Veeva features. Roles & Responsibilities: Develop comprehensive test plans and strategies based on project specifications and requirements. Perform manual and automated testing of software applications, including functional, regression, and performance testing. Document and report defects identified during testing and collaborate with development teams for resolution. Maintain detailed records o...

Department Name: Enterprise Engineering and Analytics (EEA) Role GCF: 4 Job Family: Software Development Engineer-Test I I Role Description: We seek a skilled Validation Lead to oversee and manage validation activities for data platforms and solutions . As a key contributor, you will collaborate closely with cross-functional teams to ensure that the data and analytics products follow the required validation processes, documentation, and comply with Amgens standard operating procedures, policies, and guidelines . Your expertise will be instrumental in ensuring quality and adherence to required standards so that the engineering teams can build and deploy products that are compliant . Roles & R...

What you will do In this vital role you will lead the execution of complex or novel assignments requiring strategic planning and development of new and/or improved validation techniques, deviations, and procedures. In this position you will supervise validation activities through internal audits and conduct risk assessments to identify the need for requalification and establish policies for computer system re-validation. This individual will actively participate during all phases of qualification/validation of computerized systems: evaluate projects; provide guidance and technical information to others (lead qualification/validation activities); determine and establish requirements for quali...

What you will do In this vital role, you will support the qualification, validation, and compliance processes for SAP ERP solutions and related platforms. You will work closely with senior team members, Quality, and business partners to ensure validation deliverables are executed to meet industry standards and regulatory requirements in a Life Sciences environment. Roles & Responsibilities: Execute validation deliverables for SAP ERP systems (ECC, S/4HANA, BTP, GRC, and related platforms) in alignment with Amgens procedures and regulatory expectations. Support the creation, execution, and review of validation documentation (e.g., Validation Plan, Requirements, IQ, OQ, PQ/UAT test scripts, Tr...

What you will do As an Associate System Analyst Veeva Test Engineer at Amgen, you will join the Amgens Veeva Validation Team to help develop test strategies for various Veeva releases in Amgen. You will also assist the operations team in investigating issues with validated Veeva features. Roles & Responsibilities: Develop comprehensive test plans and strategies based on project specifications and requirements. Perform manual and automated testing of software applications, including functional, regression, and performance testing. Document and report defects identified during testing and collaborate with development teams for resolution. Maintain detailed records of test plans, test cases, an...

What you will do In this vital role you will as an Associate System Analyst Veeva Test Engineer at Amgen, you will join the Amgens Veeva Validation Team to help develop test strategies for various Veeva releases in Amgen. You will also assist the operations team in investigating issues with validated Veeva features. Roles & Responsibilities: Develop comprehensive test plans and strategies based on project specifications and requirements. Perform manual and automated testing of software applications, including functional, regression, and performance testing. Document and report defects identified during testing and collaborate with development teams for resolution. Maintain detailed records o...

What you will do In this vital role you will as an Associate System Analyst Veeva Test Engineer at Amgen, you will join the Amgens Veeva Validation Team to help develop test strategies for various Veeva releases in Amgen. You will also assist the operations team in investigating issues with validated Veeva features. Roles & Responsibilities: Develop comprehensive test plans and strategies based on project specifications and requirements. Perform manual and automated testing of software applications, including functional, regression, and performance testing. Document and report defects identified during testing and collaborate with development teams for resolution. Maintain detailed records o...

Before you apply to a job, select your language preference from the options available at the top right of this page. Explore your next opportunity at a Fortune Global 500 organization. Envision innovative possibilities, experience our rewarding culture, and work with talented teams that help you become better every day. We know what it takes to lead UPS into tomorrowpeople with a unique combination of skill + passion. If you have the qualities and drive to lead yourself or teams, there are roles ready to cultivate your skills and take you to the next level. About The Role : Job Summary The Healthcare Quality Assurance (QA) System Validation Supervisor provides guidance to UPS Supply Chain So...