99 Gamp Jobs

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, drug dispensing, and visit scheduling Data entry, query management, and monitoring Document upload, versioning, and eTMF compliance Reporting and dashboard validation Perform regression testing for upgrades, patches, and system integrations. Log defects, participate in triage, and track to closure with IT/vendors. Ensure compliance with ICH-GCP, GAMP 5, 21 CFR Part 11, GDPR, and other regulatory standards. Support end-user training, readiness checks, and sign-off for system release. Provide UAT summary reports and contribute to release go/no-go decisions. Maintain UAT documentation for audits and regulatory inspections. Support process improvements, automation, and efficiency in UAT cycles. Good to Have (secondary skills) Hands-on experience with Clinical applications (e.g., Medidata Rave, Oracle InForm, Veeva CTMS, Medrio, Oracle Siebel CTMS, Veeva eTMF, IRT/IWRS systems). Knowledge of clinical trial processes (site initiation, subject enrollment, monitoring, data management, trial closure). Familiarity with UAT methodology, SDLC, and CSV (Computer System Validation) practices. Strong knowledge of ICH-GCP, FDA, EMA, and MHRA clinical trial regulations. Proficiency in defect tracking tools (e.g., JIRA, HP ALM, Veeva QMS). Excellent communication, analytical, and problem-solving skills. Ability to work cross-functionally with Clinical, QA, Data, and IT teams. Communication Immaculate communication and handles multiple clients/ projects Works in Consulting capacity Best Regards, Sanjay Kumar

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 relationship management to create clear supplier strategies (commercial, contractual and risk) for a defined element of the supplier portfolio, and will ensure the requirements contractual obligations, Procurement policy, and business unit objectives are met and evidenced in regular routines. About you Previous experience as a Supplier Relationship Manager is essential, with at least 3 years SRM FS experience desired. Experience of working within an Enterprise Risk Management framework model, with knowledge of the 3LoD model. It is essential the role holder demonstrate behaviours aligned to FILs Values and Behaviours. It is desirable for the role holder to have sound knowledge of key global regulations pertaining to Outsourcing and controls. Commercial awareness and ability to partner with Procurement to negotiate fees and contracts. Enthusiastic, self-driven and with a high level of self-motivation to overcome obstacles and a strong desire to make things happen. Strong personal presence, excellent interpersonal and communication skills, ability to establish a successful rapport, communicate and influence at all levels. Excellent organisational skills, presentation of reports and attention to detail. Strong decision-making skills. Ability to be flexible and responsive to a constantly changing environment.

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 ATTP (Advanced Track and Trace for Pharmaceuticals), and SAP QM. Proven ability to deliver validated SAP solutions in regulated environments (21 CFR Part 11, GAMP 5). Strong understanding of clinical, manufacturing, and supply chain operations in life sciences. Experience with cloud platforms and integration with digital health or IoT systems is a plus. What you"ll love about working here You can shape yourcareerwith us. We offer a range of career paths and internal opportunities within Capgemini group. You will also get personalized career guidance from our leaders. You will get comprehensive wellness benefits including health checks, telemedicine, insurance with top-ups, elder care, partner coverage or new parent support via flexible work. At Capgemini, you can work oncutting-edge projectsin tech and engineering with industry leaders or createsolutionsto overcome societal and environmental challenges. Location - Hyderabad,Bengaluru,Pune,Mumbai

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 manufacturing sites. System Configuration & Administration: Configure and customize Werum PAS-X modules including GMBRs, PVL, PMBRs, Equipment Management, Material Flow, Weigh & Dispense, EBR, and Master Data. Design and developState Diagramsand determine updates forMaster DataandEquipment Management. Integration & Interface Management: Work on SAP-MES interfaces, Level 2 (L2) integrations, and report development. Ensure seamless data flow and system interoperability. Compliance & Validation: Ensure compliance with GxP, GAMP, and 21 CFR Part 11 standards. Participate in validation activities includingIQ/OQ/PQand documentation. Project & Stakeholder Management: Act as an Offshore Lead and manage service delivery for PAS-X. Liaise with clients and stakeholders to gather requirements and provide technical solutions. Provide support forWerum PAS-X installation, upgrade, development, and configuration. Primary Skills (Must-Have): Strong hands-on experience withWerum PAS-X(Specification, Execution, Compliance & Performance Modules). Expertise inMBR creation,State Diagram design, andMaster Data configuration. Experience inPAS-X System Administrationandcustomization. Knowledge ofISA-95/S88 standardsand their application in MES design. Familiarity withSAP-MES integrationandL2 automation systems. Understanding ofpharmaceutical manufacturing processesand regulatory requirements. Secondary Skills (Good-to-Have): Programming knowledge inSQL,C#, andJava. Experience withuser management,system profile creation, andreporting tools. Exposure toITIL frameworksandIT service management. Experience inproject management,client communication, andteam leadership. IT Skills: SQL Queries C# (C-Sharp) Java Experience in: User management System profile creation System configuration and troubleshooting

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 have strong understanding of pharmacovigilance, regulations and guidelines for difference geographic location. Should have experience in reviewing the CSV deliverables such as IQ, OQ and PQ scripts. Experience of QA in FDA / EMEA regulated environment is preferred.

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 and goals

Provide expert consulting on designing, optimizing, and implementing quality management systems, ensuring alignment with industry best practices and regulations. Required Candidate profile 3+ years eClinical software exp; 8+ years in quality assurance/compliance/management within U.S. pharma; Deep knowledge of regulatory frameworks: FDA regulations, ICH GCP, 21 CFRPart 11.

As a dedicated Qualification Professional, you will be responsible for overseeing the execution of Pre-Factory Acceptance Tests (Pre-FAT), Factory Acceptance Tests (FAT), and Site Acceptance Tests (SAT) in accordance with established test protocols. Your primary role will involve engaging directly with customers to ensure adherence to test specifications and securing necessary documentation and approvals during FAT at our facilities and SAT at customer locations. You will be expected to conduct thorough testing and troubleshooting of systems, including SCADA, to ensure optimal performance. Additionally, you will monitor and address Non-Conformance Reports (NCRs) arising during Pre-FAT, FAT, and SAT stages. It is important to demonstrate a strong understanding of regulatory standards such as GMP, GEP, GAMP, and ISPE, and apply this knowledge in practice. Your responsibilities will also include guiding customers through FAT processes, working collaboratively on projects involving multiple customers, and engaging in the continuous review and improvement of internal processes to enhance efficiency and quality. Documenting all testing procedures in accordance with standardized protocols and contributing to the refinement of internal processes will be essential aspects of your role. To qualify for this position, you should have a Bachelor's degree in science, engineering, or a related field relevant to the biopharmaceutical industry. A minimum of 3-5 years of experience in the qualification and commissioning of bio pharmaceutical equipment is required. You should possess solid technical and process engineering knowledge, including proficiency in interpreting technical drawings and standards. Being organized, detail-oriented, and methodical in your approach to tasks, as well as skilled in prioritizing and managing daily responsibilities effectively, are key qualities for success in this role. Exceptional written and verbal communication abilities, a commitment to establishing positive relationships with internal and external stakeholders, and proficiency in English and the local language are highly desirable skills. Overall, as a Qualification Professional, you will play a crucial role in ensuring the successful execution of testing procedures, maintaining regulatory compliance, and contributing to the continuous improvement of processes to uphold quality standards within the company.,

Job Title: Machine Learning Engineer Job Type: Full-time About Us: Our mission at micro1 is to match the most talented people in the world with their dream jobs If you are looking to be at the forefront of AI innovation and work with some of the fastest-growing companies in Silicon Valley, we invite you to apply for a role By joining the micro1 community, your resume will become visible to top industry leaders, unlocking access to the best career opportunities on the market, Job Summary Join our customer's team as a hands-on Machine Learning Engineer, where you'll play a pivotal role in shaping, deploying, and automating end-to-end machine learning pipelines Leveraging your expertise in AWS services and MLOps best practices, you will help operationalize cutting-edge ML solutions in a fast-paced, collaborative environment This opportunity is ideal for passionate professionals who care deeply about clear communication and impactful ML systems, Key Responsibilities Design, develop, and maintain robust ML pipelines for scalable deployment in production environments, Implement and manage CI/CD workflows specific to machine learning code and artifacts, Utilize AWS core services, with a strong focus on EKS, ECS, ECR, SageMaker (including processing, training, batch transform, hyperparameter tuning), Step Functions, EventBridge, SNS/SQS, and SageMaker Model Registry, Automate and orchestrate machine learning workflows, ensuring reliability and reproducibility, Collaborate with data scientists, engineers, and stakeholders to optimize ML models and deployment strategies, Monitor, troubleshoot, and enhance ML systems for optimal performance, availability, and scalability, Maintain clear, concise, and comprehensive documentation for pipelines, deployments, and operational processes, Required Skills and Qualifications Proven hands-on experience as an MLOps Engineer or in a similar role supporting live ML applications, Expertise in AWS cloud services, especially EKS, ECS, ECR, SageMaker, Step Functions, EventBridge, SNS/SQS, and Model Registry, Deep understanding of core ML concepts and the nuances of deploying ML code in production-grade systems, Strong experience with MLFlow for experiment tracking and model management, Solid grasp of CI/CD concepts tailored to machine learning workflows, Exceptional written and verbal communication skills, with a strong emphasis on collaboration and documentation, Demonstrated ability to work on-site in Gurugram, Pune, or Bengaluru, Preferred Qualifications Exposure to advanced ML workflow automation and monitoring tools, Previous experience in high-performance, large-scale ML environments, Relevant certifications in AWS or MLOps,

As a qualified candidate passionate about delivering computer system validation and risk management approaches to support tremendous IT and business growth, you will join the IT team as part of the ITRMC (IT Risk Management & Compliance). In this role, you will interface between the quality business unit, IT, business customers, and vendors on various computer system validation projects and compliance initiatives. Over the next 3 years, the business plans to deploy major operational systems like LIMS, ERP, MES, VLMS, EBR to enhance capabilities and improve customer service, and you will play a crucial role in achieving these objectives. Your responsibilities will include providing technical and compliance expertise for the strategy and execution of computer systems validation in alignment with regulatory standards such as 21 CFR Part 11, 211, 820, GAMP, CSA. You will conduct IT change control impact assessments, develop project documentation, and lead compliance improvement initiatives. Additionally, you will run computer system validation efforts, provide coaching to stakeholders on best practices, advise on IT project execution from a risk and compliance standpoint, and offer IT audit support for internal and external audits. You will stay updated on computer systems validation approaches, industry trends, and health agency guidance, and support software supplier assessments for IT systems within the manufacturing and quality plane. In addition, you will oversee junior roles, staff augmentation, or vendor services for larger projects, ensuring IT life cycle compliance operations are carried out efficiently. The ideal candidate will have a Bachelor's degree in Computer Science, IT, or a related discipline, with 8+ years of experience in pharma/device or other regulated industries. Proficiency in English and citizenship in the U.S. or UK are required. Deep knowledge of lab systems, manufacturing systems, quality systems, and regulatory compliance processes is essential, along with experience in SDLC/GAMP and IT project management methodologies. Additional qualifications such as Lean Six Sigma, ASQ certification, and training in FDA CSA are advantageous.,

Role & responsibilities Must be aware of regulatory guideline like 21 CFR part 11, EUannex 11, GAMP 5 etc.. Must know about GAP assessment Must have exp in handling CSV of L1 , L2 system like DAS, DCS, Empower ,OSD /injectable Mfg equipment Must have knowledge for performing category 4 and 5 system Preparation and execution of validation deliverables like IRA,VP, URS,FS, CS, DS, FRA, IQ, OQ, TM, VSR Execution of qualification document without DI

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 decision-making processes, contributing to the overall success of projects and initiatives within the organization.RTR About The Role :Both SAP ECC and S/4HANA experience required in FICO (Financial Accounting and Controlling) domain.Analyze and understand business processes related to RTR and translate them into SAP solutions.Provide expert support on FI (GL, AP, AR, Asset Accounting) and CO (Cost Center Accounting, Internal Orders, Profit Center Accounting, etc.).Prepare Functional Specification (FS) documents for development activities including enhancements, reports, interfaces, and conversions.Work closely with technical teams (ABAP/Developers) to explain requirements and validate solutions.Collaborate with business stakeholders to gather and document functional requirements, especially field-level mapping and validations.Provide day-to-day functional support and issue resolution in the RTR process.Participate in system testing, integration testing, and UAT.Collaborate with business users and cross-functional teams to ensure successful delivery of enhancements or changes. Qualification 15 years full time education

Computer System Validation (CSV) Exp. :- 3-9 yrs Location :- Pune Work youll do As a part of our Technology & Transformation team, Youll: Support on IT quality systems framework design and implementation Managing the reviews and assessments for IT quality Assist in Computer System Validation (CSV) compliance of GxP processes for pharmaceutical companies or experience on quality compliance services for global consumer health care, medical devices, and pharmaceutical companies GxP Business process review Development of integrated GxP and IT compliance Standard operating procedures and guidelines GxP and IT compliance assessment Define the Validation strategy of IT Software and Systems Actively participate in the Validation Life Cycle of regulated IT projects or platforms by planning validation deliverables, working on validation documentation, participating in authoring deliverables, functional requirements definition, traceability matrix, validation protocol development, Validation testing and deviation management; and working closely with cross-functional project teams. Ensure 21 CFR Part 11 compliance for Computerized system Provide User training on CSV and increase awareness about compliance Responsible for reducing Gaps identified in various GAP/Risk Assessments existing and new computerized systems and providing a remedial action plan for compliance. Carrying out an Audit of IT systems to ensure regulatory compliance Manage the specified business/systems requirements, working closely with the designated Project Manager to facilitate the progress of the project Coach/mentor staff and provide technical leadership, as needed The key skills required are as follows: IT Quality, Regulatory, Compliance (IT-QRC) Quality guidelines mentioned by FDA, MHRA, and other regulatory bodies GxP practices and GAMP5 guidelines. Computer System Validation of various COTS products like COGNOS, IMPACT, BAELN and other related applications used in pharmaceutical industries Experience in activities like Business Analysis, Risk Identification, FRS creation and other validation testing deliverables. Good understanding & practical experience of 21CFR Part 11 and other FDA GxP regulations. Additional Skills Excellent verbal and written communication skills Experience in consulting domain to handle/manage different clients Qualifications B.E./B.Tech./MCA/MBA/M.Sc/B.Pharm/M.Pharm or similar Experience range 2 years to 8 years

This Position reports to: Senior Engineering Manager In this role, you will have the opportunity to act as a design authority for an engineering discipline with low to medium complexity. Each day, you will complete assignments on small projects or portions of larger projects in a cost-effective manner. You will also showcase your expertise by applying basic design thinking/design for excellence concepts in projects. This role is contributing to the Process Automation business for Energy Industries division based in Bangalore, India. You will be mainly accountable for: Engineering and Project Deliverables to Commissioning Involves: A person with good automation and Pharma, Biotech/API, Food & Beverage experience is required. Knowledge of Batch standards (S-88) and Good Manufacturing Practices for Batch Engineering. Batch process application engineering and implementation as per user requirement specifications. Good Batch Software Engineering experience, including development of SFCs, recipes, etc. HMI design and implementation, integrated system testing (FAT), startup and commissioning, and troubleshooting. You will join a high performing team, where you will be able to thrive Qualifications for the role Control Systems Experience: 3-5 years of experience with ABB DCS, Delta V, Rockwell, or Siemens Batch systems. Batch Standards and Programming: Experience with ISA 88 Batch Standards, Batch Engineering, Production Management/Scheduling, and Batch Management programming. Recipe Management and Batch Production: Proficiency in developing Recipe Management and Procedures for Batch Production processes. Pharma Project Execution: Expertise in executing Pharma projects following V-model and GAMP standards, including process control and automation engineering, validation/qualification, and Computer Systems validation. .Educational Background: BE/BTech/Diploma in Engineering (Control and Instrumentation or equivalent)

This Position reports to: Senior Engineering Manager In this role, you will have the opportunity to act as a design authority for an engineering discipline with low to medium complexity. Each day, you will complete assignments on small projects or portions of larger projects in a cost-effective manner. You will also showcase your expertise by applying basic design thinking/design for excellence concepts in projects. This role is contributing to the Process Automation business for Energy Industries division based in Bangalore, India. You will be mainly accountable for: Strong expertise in automation within Pharma, Biotech/API, and Food & Beverage industries. In-depth knowledge of Batch standards (S-88) and Good Manufacturing Practices (GMP) for Batch Engineering. Proficient in Batch Process Application Engineering and Implementation based on User Requirement Specifications (URS). Extensive experience in Batch software engineering, including the development of SFCs (Sequential Function Charts) and Recipes. Skilled in HMI (Human-Machine Interface) Design and Implementation. Proficient in conducting Integrated System Testing (Factory Acceptance Testing - FAT). Expertise in Startup, Commissioning, and Troubleshooting activities. You will join a talented team, where you will be able to thrive. Qualifications for the role Industry Expertise: Experience in ISA 88 Batch Standards, Batch Engineering, and developing Recipe Management and Procedures for Batch Production processes. Software & Systems: 3-5 years of experience with ABB DCS, Delta V, Rockwell, or Siemens Batch systems preferred. Project Execution: Proficiency in Pharma projects aligned with V-model and GAMP standards, including requirements documentation, detailed design, integration, testing, and on-site startup. Validation & Documentation: Knowledge of Computer Systems Validation, risk-based approaches, and developing specifications (URS, FDS, SDS) in the Pharma domain. Engineering Skills: Expertise in process control and automation using P&IDs and field instrumentation based on ISA S88 standards. Educational Qualifications: BE/BTech/Diploma in Engineering (Control and Instrumentation) or equivalent. Travel Flexibility: Willingness to travel internationally as needed (over 50% travel anticipated).

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, FS, FRA, DD, IQ, OQ, PQs, 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 areaso IT QMSo Validation/Qualificationo 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 and Professional 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)

Looking for a qualified candidate with a passion for delivering computer system validation and risk management approaches to support significant IT and business growth. As a part of the ITRMC (IT Risk Management & Compliance) team, you will work closely with the quality business unit, IT, business customers, and vendors on various computer system validation projects and compliance initiatives. Over the next 3 years, our organization plans to deploy major operational systems like LIMS, ERP, MES, VLMS, and EBR to enhance capabilities and improve customer and patient service. Your role will be crucial in achieving these objectives. Your responsibilities will include providing technical and compliance expertise for executing computer systems validation in compliance with regulatory standards such as 21 CFR Part 11, 211, 820, GAMP, and CSA. You will conduct IT change control impact assessments, develop project documentation, and artifacts, and lead compliance improvement initiatives. Additionally, you will oversee computer system validation efforts, offer guidance on best practices, risk management, and industry trends, and provide support for IT audits by internal and external entities. To be successful in this role, you should have a Bachelor's degree in Computer Science, IT, or a science-related discipline, with at least 8 years of experience in the pharma regulated industry focusing on validation of laboratory, quality, or manufacturing IT systems. Strong knowledge of lab systems, manufacturing systems, quality systems, Document Management Systems, risk management, and audits is required. Familiarity with SDLC/GAMP, Agile cGMP development, and FDA CSA is preferred, along with Lean Six Sigma and/or ASQ certification. If you have operated as a computer systems validation strategy lead, delivered validation packages for IT systems, designed compliance processes, conducted risk management, and worked on data integrity projects in a biopharma or manufacturing environment, you are encouraged to apply. Your expertise in executing computer systems validation within an SDLC framework, collaborating with IT SMEs, and driving cultural change will be highly valued. The ideal candidate must be proficient in English and be a U.S. or UK citizen. If you are ready to take on this challenging yet rewarding role and contribute to our organization's growth and compliance objectives, we look forward to receiving your application.,

I nviting applications for the role of Principal Consultant CSV Analyst In this role, CSV Analyst will prepare and execute test documentation for computerized systems and provide support in the troubleshooting of issues during test execution. Responsibilities Assist with the development of system requirements and specifications to ensure requirements that are testable, and 21 CFR Part 11 requirements are met Evaluate proposed changes to validated computer systems and recommend level of validation activities required Identify and qualify all computer systems which impact cGMP operations using a risk-based methodology Develop CFR Part 11 computer systems validation plans, qualifications test protocols, traceability matrices, reports, IQ/OQ protocols and all documents, and deliverables within the scope of the validation plan Where applicable, ensure proper level of software documentation from suppliers (detailed software specifications, architecture diagrams, deployment specs), as well as identification of associated unit and deployment testing prior to release Develop and maintain test plans, test scripts and user acceptance tests and manage the execution of test plans Execution of validation plans and validation documents Qualifications we seek in you! Minimum Qualifications / Skills BE/B Tech Preferred Qualifications/ Skills Familiar with writing tests for Web-based software architectures Knowledge of Software validation process and testing methodologies, preferably in a highly regulated environment (medical, aerospace or equivalent). Familiarity with the processes and legal requirements for pharmaceutical or medical device industry (cGMP's, 21CFR part11, GAMP) would be a plus. Critical thinker and problem-solving skills Team player Good level in English Great interpersonal and communication skills Looking for Immediate to 45 days joiners.

Seeking a CSV Consultant to work on a variety of validation projects including manufacturing systems, lab systems, risk assessments, etc. Some of the work may be done remotely, some at client sites and others at one of our offices. Immediate start date Job Responsibilities: Responsible for the Computer System Validation processes of the company Maintain expertise in current and emerging cGMP requirements and quality trends (e.g., 210, 211, 820, and 21 CFR Part 11) Work independently on and successfully solve problems and complete/qualify a system within given constraint of scope, time and schedule Lead system qualification efforts and be the primary client contact for coordinating work, reporting status, resolving issues, and addressing change orders as they apply Minimum Requirements: Minimum degree requirement - Bachelor's degree with at least 10+ years of experience Must be willing to travel regionally and/or nationally throughout India Candidates must have excellent verbal communication and technical writing skills Experience in generation and execution of protocols and procedures related to different areas of qualification and validation Expertise in ISPE GAMP5, ICH Q8, ICH Q9, ICH Q10, 21 CFR Part 11, Computerized System Validation, Equipment Qualification, and Validation Change Control Working knowledge of protocol development for validation of complex computer systems (e.g., multiple GAMP classes of systems); ability to develop Installation, Operational, and Performance Qualification documents Experience in execution of system validation lifecycle deliverables Experience in project execution within at least one area of systems validation (e.g., laboratory equipment, facilities utilities, manufacturing equipment) Proficient in Microsoft Word, Excel, Power Point, and Project Ability to plan and manage own work All candidates must be legally eligible to work in India

Job Title: Pharma Manufacturing Process Analyst / Manufacturing Systems Specialist Job Summary: We are seeking a skilled Manufacturing Systems Analyst with strong domain expertise in pharma manufacturing processes and experience working with pharmaceutical manufacturing systems (MES, SCADA, DCS, Historian systems, etc.). The role involves review and analysis of manufacturing data, including audit trail reviews , alerts , and alarms monitoring , to support digital operations and ensure regulatory compliance. Key Responsibilities: Act as a functional SME for pharma manufacturing processes , providing process insights to support system operations and investigations. Review and analyze audit trail data generated from manufacturing systems to ensure data integrity and compliance with ALCOA+ principles. Perform periodic review of alerts , alarms , and exception logs as part of routine monitoring and deviation investigations. Collaborate with production, QA, and IT teams for resolution of issues related to manufacturing systems. Support the digitization and continuous improvement initiatives in manufacturing areas. Participate in system validations, including URS development, system configuration reviews, and functional testing. Prepare and maintain SOPs and system documentation related to manufacturing systems usage and monitoring. Train end-users on manufacturing systems functionalities and regulatory requirements. Required Skills and Qualifications: Strong understanding of pharma manufacturing processes (Batch Processing, Equipment Usage, Environmental Monitoring, etc.). Hands-on experience working with Pharma Manufacturing Systems (MES, DCS, SCADA, Historian platforms). Good knowledge of audit trail review and interpretation of manufacturing system logs. Understanding of alerts , alarms , and deviation data as part of electronic record review. Familiarity with data integrity guidelines (21 CFR Part 11, EU Annex 11, WHO TRS). Experience in handling system compliance documentation (SOPs, URS, validation reports). Ability to collaborate effectively with QA, Manufacturing, and IT stakeholders. Preferred Qualifications: Knowledge of GAMP 5 , CSV principles, and pharma regulatory requirements. Experience in data review from systems like Siemens Simatic, Emerson DeltaV, Rockwell Automation, PAS-X, or similar MES/DCS platforms . Exposure to Industry 4.0 and digital transformation initiatives in manufacturing.

Major Purpose of the Job: (Exactly spell out key deliveries/results expected from this job) Person should have minimum 12+ years of experience in SAP-PP, SAP-QM, SAP-PM modules Should have implementation experience of S4HANA (Minimum one project) Ensuring Smooth Functioning of SAP-PP/QM/PM modules. To Provide Support in SAP-PP/QM/PM modules for all companies of Cadila. This will include SAP-PP/QM/PM module configuration also. Principal Accountability: (Please write all the major jobs that the employee is required to carry out ) Supporting users in Day to day issues in SAP-PP/QM/PM modules for all companies of Cadila. Knowledge on Product costing (Production order/Process order), MRP, Order execution, Batch management, Make to stock & Make to order scenarios are required. Knowledge on PP-PI (continuous process industry) is essential Coordination with SAP technical team & user to resolve Issues. Good knowledge on other SAP modules like MM, SD, and QM is essential. Knowledge of Functional enhancement Knowledge of FIORI Should make Functional specification for project, enhancement, report development etc. Knowledge of CSV (Computer system validation) will be consider as added advantage

Responsibilities: Manage CSV projects from start to finish. Ensure compliance with GAMP, GDP, CapA, GXP, IT Compliance & LIMS standards. Collaborate with cross-functional teams on system validation. Free meal Cafeteria Food allowance Shift allowance Over time allowance Travel allowance Sales incentives Annual bonus Performance bonus Marriage & childbirth gifts

Job Title: CSV Engineer Location: Bangalore Experience: 2-4 years Industry: Pharmaceutical / Biotechnology / Lifesciences About the Role: We are looking for a CSV (Computer System Validation) Engineer with hands-on experience in the pharmaceutical, biotechnology, or life sciences sectors. You will be responsible for ensuring that systems are validated in compliance with regulatory requirements and internal quality standards. Key Responsibilities: Perform validation activities for GxP computerized systems (planning, risk assessment, URS, IQ, OQ, PQ, summary reports) Prepare and review validation documentation in line with 21 CFR Part 11, EU Annex 11, and other regulatory guidelines Conduct impact assessments and periodic reviews for existing validated systems Support audits and inspections by presenting CSV documentation and processes Collaborate with QA, IT, and business users to ensure validation deliverables are met within timelines Guide project teams on validation requirements and risk-based approaches Ensure data integrity compliance across systems and processes Key Requirements: Bachelors or Masters degree in Lifesciences, Pharmacy, Biotechnology, or related field 2-4 years of hands-on experience in computer system validation within pharmaceutical, biotech, or life sciences industries Strong knowledge of GxP regulations, 21 CFR Part 11, EU Annex 11, and data integrity requirements Experience with validation of ERP, LIMS, QMS, or other laboratory/manufacturing systems preferred Excellent documentation and communication skills Ability to work independently and in cross-functional teams

Hi, We are having an opening for Manager IT-MES & L2 project coordinator at our Halol/Baska(Gujarat) location. Job Summary : We are seeking a seasoned professional with 7-9 years of experience in the pharmaceutical industry, including hands-on expertise in Manufacturing Execution Systems (MES) and L2 integration. The Site Project coordinator for MES Implementation will be the primary coordinator for all MES-related activities at the Halol / Baska sites. This role demands dedicated full-time support to the project to ensures smooth execution, alignment with the global MES strategy, and timely delivery of milestones to enhance manufacturing efficiency, compliance, and digital transformation. The role will work closely with internal teams including QA, IT, SAP, business users, and L2 integrations as well as external vendors and infrastructure leads. Responsibilities include stakeholder management, managing project timelines, risks, and dependencies, ensuring infrastructure readiness, facilitating change management, and maintaining compliance with site validation and quality standards. As the single point of contact for MES implementation at the site, the site coordinator plays a critical role in driving collaboration and successful deployment. The ideal candidate will ensure adherence to global regulations (FDA 21 CFR Part 11, EU GMP, GAMP5) Previous experience with Werum (Korber Pharma) for pharma industry is a big plus Areas Of Responsibility : Project Coordination: Lead and coordinate all MES implementation activities at the site, ensuring alignment with the global MES strategy. Stakeholder Management: Serve as the single point of contact for site-level stakeholders, including QA, QA IT, IT, SAP, and business users (Production & Engineering) Vendor & Partner Collaboration: Work closely with MES vendors, infrastructure teams, and integration partners to ensure smooth execution. Timeline & Risk Management: Manage project schedules, track milestones, identify risks, and implement mitigation plans. Infrastructure & Readiness: Ensure site infrastructure (network, servers, systems) is ready and validated for MES deployment. Compliance & Validation: Oversee adherence to site quality standards, IT validation (CSV), and regulatory requirements. Communication & Reporting: Maintain clear and timely communication with the Global Project Manager and other stakeholders; provide regular updates and escalate issues as needed. Change Management: Facilitate change control processes and support user readiness and adoption. Educational Qualification : Bachelors degree in Engineering, Information Technology, Computer Science, Production, Pharmaceutical Sciences, or a related technical field. Preferred: Masters degree (e.g., MBA, M.Tech, M.Pharm) with specialization in Project Management, Operations Management, Industrial Automation, or Pharmaceutical Technology. Specific Certification : PMP for structured project execution (Preferred) GAMP5 or CSV Training for compliance in regulated environments Experience : 9 to 10 years of experience managing IT or digital transformation projects, preferably in pharmaceutical manufacturing. Hands-on experience with MES platforms, L2/PLC systems, and SAP integration and Edge Cloud IoT. Proven track record in project planning, stakeholder coordination, and cross-functional team leadership. Strong background in GxP compliance, CSV, and validation protocols (IQ/OQ/PQ). Experience working on the shop floor and with QA, IT, and business teams in a regulated environment. Skill (Functional & Behavioural): Functional: Strong project management expertise in IT/digital systems, Knowledge of MES platforms, L2/PLC systems, and SAP integration, Familiarity with GxP, CSV, and validation protocols (IQ/OQ/PQ), Understanding of pharmaceutical manufacturing processes and shop floor operations, Proficiency in stakeholder coordination and cross-functional collaboration Behavioral: Strong communication and interpersonal skills, Proactive problem-solving and risk management, High attention to detail and compliance mindset, Ability to work under pressure and manage multiple priorities, Team-oriented with a focus on collaboration and accountability Additional Skills: (Good to have) Knowledge of data analytics tools Edge Cloud deployment experience with (IoT and and IIoT) L2 integration with MES MES integration with SAP Understanding of network and databases