142 Gamp Jobs - Page 2

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...

Risk professional with proven ability to identify, assess, and mitigate operational risks across people, processes, and systems. Execute day-to-day operational risk and control management across functions. Conduct risk assessments, self-assessments, and ensure timely reporting. Track corrective actions, risk registers, and loss events with preventive action plans. Support implementation of risk programs (process, people, InfoSec, BCP, compliance, vendor & records management). Investigate incidents (fraud, security, data breaches) and identify fraud risk indicators. Analyze data for suspicious patterns and operational impacts. Drive stakeholder engagement, awareness sessions, and integration ...

1) Ensuring their accounts comply with the requisite audit standards 2) Providing a robust and clear perspective to audit committees and 3) Providing critical information for stakeholders. Our Service Offerings include External Audit, Financial Accounting Advisory Services (FAAS), IFRS & US GAAP conversion, IPO and other public offering, Corporate Treasury - IFRS 9 accounting & implementation support etc. Your key responsibilities Experience of working on FS clients is preferred IT audits including statutory and internal audits IT General Controls (ITGC) testing IT Application Controls (ITAC) testing / IT Automated Business Controls testing IT Infrastructure risks and control assessments IT ...

IT Infrastructure/Systems Architecture work involves developing the core technical platform, capabilities, and services that support business processes and data including: Mapping the relationships between IT platform/infrastructure components (i.e., Technology End Users, IT Systems Software & Hardware, and Info-Communications Transmission Networks) Identifying the key technology interactions and dependencies across systems/platforms impacting the organizations ability to achieve integration, compatibility, and performance targets Evaluating total cost of ownership and return on investment of various IT platform/infrastructure alternatives Experienced Specialist in one specialized discipline...

Dear Candidate, Greetings from Shell Infotech! We are pleased to share an exciting opportunity with one of our esteemed client.Please find the job description and relevant details below for your review. If this opportunity aligns with your interest and profile, kindly respond to this email with your updated CV at premalatha@shellinfotech.com Mode of Hire: Contract to Hire (Initially 6 months-1 Year contract with extension and direct conversion with Client-Deloitte based on your performance) Location: Hyderabad, Bangalore, Chennai, Pune, Mumbai, Gurgaon, Kolkata Mode of work: Hybrid-3days from Office Total Exp:5-14 Years Role/Skill Set: Analyst/Consultant Computerized System Validation Servic...

Project Role : Application Developer Project Role Description : Design, build and configure applications to meet business process and application requirements. Must have skills : SAP FI CO Finance Good to have skills : NAMinimum 5 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Application Developer, you will design, build, and configure applications to meet business process and application requirements. A typical day involves collaborating with various teams to understand their needs, developing solutions, and ensuring that applications function effectively to support business operations. You will engage in problem-solving and decisi...

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

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...

We are looking for a skilled Validation Engineer with 5 to 8 years of experience. The ideal candidate will have a strong background in validation and CSV experience, as well as knowledge of IQ, OQ, and PQ processes. Roles and Responsibility Design and develop test cases for validation purposes. Collaborate with cross-functional teams to identify and resolve issues. Develop and maintain documentation of validation processes and results. Analyze data to identify trends and areas for improvement. Participate in audits and ensure compliance with regulatory requirements. Provide training and support to junior team members. Job Requirements Bachelor's or Master's degree in Engineering (BE/BTech) o...

Key Skills: - Application/Product development testing and experience in Computer Systems Validation (CSV) - Experience in QMS, Regulatory Requirements, GxP Compliance, and Good Documentation Practices - Strictly adhereing to Business SOPs, cost & coverage, requirement specifications & formulation of Test Cases in HP ALM for the Functional, Integration, end-to-end, Usability, and smoke testing. - Experience in the development of Qualification test scripts (IQ,OQ, PQ and VSR) for CSV projects - Good knowledge of CSV, GAMP5, 21CFR Part 11, and good documentation practices - Knowledge on HP ALM and Jira Tool and validation approval process using ALM

Responsibilities: Ensure compliance with regulatory requirements through CSV processes. Implement LIMS, Labware Lims & DMS systems. Conduct CSV activities for equipment validation. Health insurance Annual bonus Provident fund Flexi working

Educational Requirements Master of Pharmacy,Master Of Technology,Bachelor of Pharmacy (Honors),Bachelor Of Science,Bachelor of Engineering,Bachelor Of Technology 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...

As a CSV (Computer System Validation) Consultant/ Lead your responsibilities includes developing validation plans, protocols, and test scripts; executing tests; performing risk assessments; documenting all processes; and ensuring that systems adhere to regulatory requirements throughout the lifecycle. Required Skills and Qualifications Technical Skills: Proficiency with validation software (e.g., MS Project, ALM, Veeva Vault) and an understanding of manufacturing and supply chain applications. Regulatory Knowledge: Strong understanding of GxP, FDA regulations, and other relevant industry standards. Analytical and Problem-Solving Skills: Ability to assess systems for quality and compliance, a...

Experience 4-6 years Work location: Bangalore Experience in PLC / HMI software development in Discrete Manufacturing domain preferably in Assembly line and packaging machines Expertise in IEC1131-3 PLC programming languages - SFC, FBD, Ladder logic, Structured Text Reading and understanding of customer documents like E-Plan, CTS, 3D Models and wiring drawings Development experience in atleast two of the PLC programming tools like TwinCAT, CODESYS, Simatic STEP 7, RSLogix, IndraWorks Knowledge of Industrial Automation protocols like OPC-DA / UA, Modbus, Profibus Experience in interfacing with external devices like Servo Drives, Motion Controllers, Screwers Hands-on experience in any HMI build...

Position Overview: We are seeking a knowledgeable and results-driven CSV Engineer to join our team, specializing in providing expert validation services to our clients. In this role, you will work closely with a diverse range of companies, ensuring the compliance, reliability, and quality of their computerized systems while adhering to industry regulations and best practices. Key Responsibilities: Validation Strategy and Planning: - Collaborate with clients to develop tailored validation strategies and plans based on their specific needs and regulatory requirements. - Assess project scope, goals, and timelines to design efficient validation approaches. Validation Execution: - Design, develop...

Key Responsibilities : Design and develop sophisticated and attractive automation solutions for pharmaceutical equipment (PLC, SCADA, HMI), leveraging state of the art tools and technologies. This includes: Lead the evaluation and selection of automation tools and frameworks, ensuring scalability, reliability, and ease of use. Lead the planning from development to validation phase. Write documentation required by the project (specifications, design report, user instruction, ) in compliance with internal procedures & external requirements (ISPE GAMP, GMP, Eudralex, FDA & EHS requirements). Maintain our product up to date, support our customers/services team for automation issues. Find the bes...

Job Purpose We are looking for a qualified IT QA professional to support the implementation, validation, and compliance of electronic systems in accordance with global regulatory standards. The role ensures the effective functioning of key systems like TrackWise, AmpleLogic, LIMS, SAP, and eLMS while driving data integrity, compliance, and quality excellence across business operations. Roles & Key Responsibilities Ensure implementation and compliance of electronic systems (TrackWise, AmpleLogic, LIMS, SAP, eLMS, MES) as per global regulatory guidelines (USFDA, EU, WHO, PMDA, CDSCO, etc.). Review and support validation/qualification of software (DQ, IQ, OQ, PQ), ensuring timely closure of pro...

Job Purpose We are looking for a qualified IT QA professional to support the implementation, validation, and compliance of electronic systems in accordance with global regulatory standards. The role ensures the effective functioning of key systems like TrackWise, AmpleLogic, LIMS, SAP, and eLMS while driving data integrity, compliance, and quality excellence across business operations. Roles & Key Responsibilities Ensure implementation and compliance of electronic systems (TrackWise, AmpleLogic, LIMS, SAP, eLMS, MES) as per global regulatory guidelines (USFDA, EU, WHO, PMDA, CDSCO, etc.). Review and support validation/qualification of software (DQ, IQ, OQ, PQ), ensuring timely closure of pro...

UAT Tester - CTMS & CDM applications Keywords Clinical Systems, Safety Systems, 21 CFR part 11, GAMP 5, ICH, EMEA, MHRA regulations Roles and Responsibilities Must Have 48+ years of experience in IT testing/validation, with 2–4+ years in clinical trial systems. Collaborate with Clinical Operations, Data Management, Biostatistics, and IT teams to gather UAT requirements. Develop UAT strategy, test plans, test cases, and traceability matrices mapped to URS (User Requirements). Execute UAT test scripts for CTMS, EDC, eTMF, IRT/IWRS, eCOA/ePRO, and integrations with Safety and Regulatory systems. Validate workflows such as: Site/investigator setup and activation Subject enrollment, randomization...

We are a team of SysOps/DevOps engineers with one goal in mind -to keep your online business up and running 24/7. Solving problems is our thing, but we believe that dealing with the same issues over and over again.

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 ...

Your Role Design and implement SAP solutions tailored to the unique regulatory and operational needs of the life sciences industry. Collaborate with R&D, manufacturing, quality, and compliance teams to align SAP systems with GxP and FDA/EMA requirements. Lead SAP S/4HANA implementations across pharmaceutical, biotech, and medical device domains. Ensure integration of SAP with lab systems (e.g., LIMS), MES, and serialization platforms. Drive digital transformation initiatives focused on traceability, patient safety, and operational efficiency. Your Profile 12-16 years of experience in SAP, with a strong focus on life sciences industry processes and compliance. Expertise in SAP S/4HANA, SAP AT...

About The Role We are seeking a skilled and experienced MES Engineer with hands-on expertise inKrber Werum PAS-Xto support manufacturing operations in a regulated pharmaceutical or life sciences environment. The ideal candidate will have a strong technical foundation, validation knowledge, and excellent communication skills to effectively bridge the gap between technical teams and business stakeholders. Key Responsibilities:- MBR Design & Development: Design and create complex Master Batch Records (MBRs) for Weighing & Dispensing, Manufacturing, and Packaging processes. Analyze site-specific requirements and translate them into functional MBRs. Validate MBRs for deployment across manufacturi...

Key Role and Responsibilities: Should have experience in CSV (Computer System Validation) in Life Sciences domain. Should have good knowledge of GxP regulations and GAMP 5 Guidelines. Should have a good knowledge of 21 CFR part 11 and EU Annex 11 regulations. Should have experience in defining the validation strategy, approach, and alignment with customer on QMS. Should have good knowledge of Good Documentation Practices. Should have experience in authoring of CSV deliverables such as Validation Plan, Test Plan, RTM, Test Summary and Validation Summary Report, GxP Assessments, 21 CFR Part 11 assessments and System Release Notice. Should have experience of Validating Safety Systems. Should ha...

Deloitte is looking for Deputy Manager | CSV | | SAP to join our dynamic team and embark on a rewarding career journey Assist the Manager in the day-to-day operations of the business, including setting goals, developing strategies, and overseeing the work of team members Take on leadership responsibilities as needed, including managing team members and making decisions in the absence of the Manager Identify and address problems or challenges within the business, and develop and implement solutions Collaborate with other departments and teams to ensure smooth and efficient operations Maintain accurate records and documentation Contribute to the development and implementation of business plans...