70 Gamp Jobs

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

Performing audits of all Dr. Reddy’s Laboratories manufacturing, packing, testing, development centers and distribution warehouses as per the audit schedule. Primarily performing internal audits of CTO, FTO and R&D Sites. Performing GAP assessment of the new/revised regulatory guidance documents, USFDA warning letters / form 483s to evaluate the current approved documents for compliance / improvements or requirement of new procedures and harmonizing and implementing the best practices across sites. Review of audit responses and tracking the CAPA generated out of internal audits, regulatory audits, customer audits, cross-applicable CAPAs through OCMS, Warning letters & 483 forms gap assessment of all sites for timely and effective implementation. Performing on site verification or review of the documented evidence for compliance of previous audit observations. Preparation and review of harmonized Standard Operating Procedures and Guidance documents which shall be implemented at Global, FTOs, CTOs business units and related supporting functions. Assessing the impact on the procedures during implementation of changes in IT applications. Overview harmonization of CSV/IT compliance practices across Dr Reddy’s sites. Ensuring timely assessment and implementation of pharmacopeia and regulatory guidance updates w.r.t. CSV/IT compliance procedures across Dr Reddy’s sites. Ensuring review and implementation of simplification procedure for different CSV/IT compliance procedures across Dr Reddy’s sites to reduce redundancy. Tracking and revision of SOPs identified during SuCCEED drive and Re-Imagine QMS. Conducting training sessions for the approved documents before implementation of the procedure. Preparation of questionnaire for SOP in order to evaluate the effectiveness of training imparted. Initiation and review of quality notifications raised for revision, preparation of documents as per identified requirements. Timely communication to stakeholders about revision/implementation of SOPs. Providing data for monthly report. Providing support to sites during regulatory audits for review of systems / documents. Any work assigned by the Lead and Head of the Department Qualification M.Sc (Chemistry) with 15+ years of Pharma experience in IT/CSV quality Additional Information About the Department Global Manufacturing Organisation (GMO) At Dr. Reddy's Laboratories, we are dedicated to making a meaningful impact on global healthcare through precision manufacturing and innovation. With a legacy of excellence, we are a leading force in the pharmaceutical industry. We operate 19 state-of-the-art manufacturing plants across Hyderabad, Vizag, Baddi, Mexico, Shreveport, and Mirfield, comprising 8 OSD facilities, 3 Injectables facilities, and 8 API facilities. Benchmarking manufacturing processes and continuous operational excellence are at the core of our capability to deliver quality medicines to our patients in 66 countries. We manufacture a portfolio of complex APIs and 1,150+ drug master files across key therapy areas such as Oncology, Cardio-vascular, Central Nervous System and Anti-Diabetes. he World Economic Forum has recognised our largest manufacturing facility in Bachupally, Hyderabad, as part of its Global Lighthouse Network. We aspire to be the most efficient pharma operations in the world. Our productivity improvement and digitalisation efforts are key to staying competitive, meeting business imperatives, and meeting our ambitious ESG goals. Building such ‘factories of the future’ is integral to innovation and to build healthcare of the future. Benefits Offered At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs. The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself. Our Work Culture Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic. For more details, please visit our career website at https://careers.drreddys.com

About the Opportunity Job TypeApplication 31 July 2025 Title Supplier Relationship Manager Department Procurement Location Gurgaon, India Reports To Head of Supplier Relationship Manager Level Grade 5 We are proud to have been helping our clients build better financial futures for over 50 years. How have we achieved thisBy working together - and supporting each other - all over the world. So, join our team and feel like youre part of something bigger. About the team Fidelity Internationals Global Procurement function provides Source to Pay and Third Party Risk Management services to FIL colleagues globally. It comprises approximately 95 colleagues, based across UK, India, Continental Europe, and Asia Pacific, overseeing spend of ~$700m in 26 countries. The existing SRM function is established to ensure alignment and a drive best practice supplier relationship management across all FIL supplier management activity globally. The SRM will be part of a global team covering UK / Ireland / India, forming a broader community with ~6 colleagues in Gurgaon who will undertake common supplier management tasks and providing CoE support. The SRM will demonstrate behaviours which meet FILs core values, evidence an ability to work collaboratively across FIL, and role model leadership on key programmes such as ESG. 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 tosenior 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. Feel rewarded For starters, we will offer you a comprehensive benefits package. We will value your wellbeing and support your development. And we will be as flexible as we can about where and when you work finding a balance that works for all of us. It is all part of our commitment to making you feel motivated by the work you do and happy to be part of our team. For more about our work, our approach to dynamic working and how you could build your future here, visit careers.fidelityinternational.com.

We are looking for a skilled Kneat CSV Professional with 6-12 years of experience to join our team at IDESLABS PRIVATE LIMITED. The ideal candidate will have a strong background in Recruitment / Staffing and excellent skills in Kneat CSV. Roles and Responsibility Manage and implement Kneat CSV solutions for clients. Collaborate with cross-functional teams to identify and prioritize project requirements. Develop and maintain technical documentation for Kneat CSV projects. Provide training and support to clients on Kneat CSV tools and features. Troubleshoot and resolve issues related to Kneat CSV implementation. Analyze and optimize client data processing workflows using Kneat CSV. Job Requirements Strong knowledge of Kneat CSV principles and practices. Experience working with large datasets and complex data processing systems. Excellent communication and interpersonal skills. Ability to work independently and as part of a team. Strong problem-solving and analytical skills. Familiarity with industry-standard data integration tools and technologies.

CSV L1/L2 Support Validating, Reviewing and updating validation documentation Hands on exp in CSV principles and GxP compliance. Experience in validation practices with hands on exp in 21 CFR Part 11/ EU Annex 11 /GAMP 5 Guidelines /GxP Standards

Minimum 10 - 12 years of experience in handling complex large transformation projects Experience in Client Relationship Management – key client stakeholders, understanding their requirements and Outsourcing ability to meet them Experience of leading large teams located across multiple cities in India and across the world. Experience of Driving Digital Transformation across a portfolio of accounts Demonstrates a breadth and depth of operational service delivery management expertise. Preferred: Ability to create technical designs based on functional designs, including, mockups, process and data flow diagrams, etc Ability to gather critical information from meetings with various stakeholders and produce useful reports. Ability to conduct market research for product development Knowledge of cloud platforms (Fundamentals of GCP/AWS/Azure) GDPR, HIPAA/GXP compliance, ERP and SAP application Role Lead the delivery of multi-functional, large-scale Cloud transformation projects Conduct a thorough review of all components in the Project/Program Plan: scope, deliverables, time frame, and cost Stakeholder management ( Internal and external ) Manage the risks, issues, scope changes, unplanned events and other actions of the project and regularly track them to meet the expected outcomes and timelines, building mitigation plans as the program evolves. Work closely with Developers, BA, Quality, Engineering, and cross-functional team to resolve issues that arise during design, implementation and in post-production. Work with external and internal partners on integration and product expansion opportunities.

Experience in CSV, GAMP, GXP, 21CFR, Part11. Experience in Documentation Writing Good Communication skills. NP - Immediate to 15 Days

Role: The purpose of the role is to provide assurance on the quality of deployment for the assigned accounts and support in establishing mechanisms that enhance and sustain customer satisfaction levels. The role is expected to support in enhancing customer advocacy by predicting and preventing customer escalations & dissatisfactions and drive a culture of continuous improvement in the assigned accounts. Do: Implement deployment quality strategy for the assigned Accounts Provide inputs in the development of strategy for the assigned accounts while considering the quality standards, client expectations, quality, and monitoring mechanisms Review and reallocate the priorities to align with the overall strategy of the line of business / business unit Quality control and Customer satisfaction Support the completion of Annual Customer Satisfaction survey by ensuring completion of survey by the account customers, representatives for various projects within the account. Ensure completion of survey and address any queries in a timely manner. Support in conceptualizing the action planning by communicating with clients and interacting with Delivery Managers, vertical delivery heads and service delivery heads Drive the account wise tracking of action planning identified for sustained CSAT in various projects. Drive the Quarterly pulse survey for selected accounts or projects for periodic check-ins. Support the Account Leadership teams for tracking and managing client escalation for closure. Early Warnings and Business partnership Drive the implementation of mechanisms for preventing client escalations / dis-satisfactions by creating an early warning system in DigiQ covering aspects like delivery quality, delivery schedule, resources constraints, financial issues (overloading of effort / over-run potential), productivity, and slippages on milestones. Participate in Monthly and Quarterly Business review along with Business and Account leadership to ensure adherence of defined quality processes, define new life cycle models and ensure gating processes are followed the projects within the accounts. Drive the upskilling of delivery teams on quality management tools, knowledge management and create mechanisms for sharing of best practices. Support the collection of metrics on the performance / health of process and regular publishing of compliance and metrics dashboards. Continuous Improvement Drive a culture of continuous improvement in the assigned accounts to ensure enhance efficiency and productivity of resources Create mechanisms between the projects in the account for sharing knowledge, quality issues, risk mitigation methods within the accounts to drive the continuous improvement Plan and drive year on year improvement goals in various projects by way of process streamlining & improvements and automation, leading to cost savings and / or efficiency Support the collection of metrics to show the improvements- efficiency / productivity improvement. Team Management Team Management Clearly define the expectations for the team Assign goals for the team, conduct timely performance reviews and provideconstructive feedback to own direct reports Guide the team members in acquiring relevant knowledge and develop theirprofessional competence Drive geography specific trainings for the quality team, designed basis the statutory norms that apply in different countries Ensure that the Performance Nxt is followed for the entire team Employee Satisfaction and Engagement Lead and drive engagement initiatives for the tea Track team satisfaction scores and identify initiatives to build engagementwithin the team Mandatory Skills: SAP FS-CM Functional. Experience: 8-10 Years.

Job description BMS Validation Project - Execution SCADA Validation Project - Execution PLC System Validation Project - Execution To Handle the site engineers as per the project given by Head / Senior To prepare the work reports related to projects

Hi, We are having an opening for Manager IT - MES SME at our Halol or Baska(Gujarat) location. Job Summary : We are seeking a seasoned professional with 6-8 years of experience in the pharmaceutical industry, including technical and functional experience in MES & L2 systems. The Site SME MES Project is a key functional and technical expert responsible for supporting the successful implementation of the Manufacturing Execution System (MES) & L2 at the Halol & Baska pharmaceutical manufacturing sites. This role ensures that site-specific manufacturing processes are accurately captured and reflected in the global MES solution. The SME is also accountable for leading site-level validation activities and technical owner responsibility , and managing all GxP documentation related to the MES & L2 system. The Site SME is the go-to authority for end-to-end MES product knowledge. This includes a deep understanding of system functionality, configuration, and compliance requirements.The SME also serves as the first point of contact for any MES front-end application issues, supporting users in troubleshooting, training, and ongoing system usage post-go-live. 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 : MES Implementation: Representing site-specific needs during MES design, configuration, and deployment. Validation Leadership: Leading IQ, OQ, PQ, UAT, and traceability matrix execution. Documentation Ownership: Managing GxP documentation (URS, FS, DS, test cases, validation plans/reports). MES Product Expertise: Maintaining deep knowledge of MES functionality and architecture. Front-End Support: Acting as the first point of contact for MES application issues and user support. Training & Adoption: Delivering training and ensuring user readiness for MES usage. Data Management: Supporting data collection, migration, and master recipe creation. Audit Readiness: Ensuring all documentation and systems are compliant and audit-ready. 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 Industrial Automation, Pharmaceutical Technology or related technical fields Specific Certification : GAMP 5 for system validation in regulated environments. CSV (Computer System Validation) for compliance with GxP. MES Platform Certifications e.g., Werum PAS-X, Siemens Opcenter, or Rockwell 21 CFR Part 11 Compliance Training for electronic records and signatures Experience : 6 to 8 years of experience Pharmaceutical Manufacturing: Strong understanding of pharma shop floor operations and regulatory requirements. MES or Digital Systems: Prior hands-on experience with MES platforms or similar systems in GxP-regulated environments. Validation Expertise: Proven experience in validation documentation and execution, especially for GxP Category 4 & 5 systems. Application Support: Experience in resolving front-end MES issues and supporting end-users post-deployment. Audit Experience: Familiarity with audit processes and documentation expectations Skill (Functional & Behavioural): Functional: MES system configuration, deployment, and validation, Front-end application troubleshooting and user support, GxP and 21 CFR Part 11 compliance, Validation protocol development and execution (IQ, OQ, PQ, UAT), Documentation management (URS, FS, DS, traceability matrices), Data migration and master recipe creation 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, Detail- oriented with a focus on compliance and quality, Proactive problem-solving and decision-making, Comfortable working on the shop floor and in technical environments 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

Educational Master Of Technology,Bachelor Of Science,Bachelor Of Technology,Bachelor of Engineering,Bachelor of Pharmacy (Honors),Master of Pharmacy 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, PQ’s, 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 areasoIT QMSoValidation/QualificationoRisk management. oHandling of defects/Deviations oInvestigations oCAPA Handling oTest 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 : 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)

Role & responsibilities Strategic Responsibilities: Define and govern the corporate CSV strategy across all units/sites for GxP systems, including SAP HANA. Lead enterprise-wide validation projects ensuring alignment with GAMP 5 , 21 CFR Part 11 , EU Annex 11 , and global data integrity expectations. Establish and monitor corporate SOPs, templates, and risk-based approaches for computer system validation. SAP HANA Specific Responsibilities: Lead validation of SAP S/4HANA (MM, QM, PP, and Z-reports, workflows, GRN process) across GxP operations. Prepare and maintain validation documentation including URS, Functional Specs, Test Scripts (IQ/OQ/PQ), RTM, and final reports for SAP HANA modules. Coordinate with IT, SAP consultants, and business users to ensure change management, role-based access control(RBAC), audit trail configuration, and secure workflows. Evaluate SAP-integrated systems (e.g.,LIMS, QMS, DMS) and their GxP compliance status. Cross-System & Governance Responsibilities: Ensure centralized control and compliance of all validated GxP systems across manufacturing, QC, QA, warehouse, and R&D operations. Conduct CSV risk assessments, gap analyses , and ensure mitigation plans are implemented across systems. Support system onboarding, upgrades, and infrastructure changes from a validation standpoint. Lead or support regulatory inspections and customer audits as CSV SME. Develop and lead training programs on computer system validation, data integrity, and regulatory compliance. Manage a team or act as a corporate mentor for site-level CSV resources. Preferred candidate profile: Technical Competencies: Strong knowledge of: SAP HANA MM, QM, PP, GRN workflows, custom Z-reports GAMP 5 / V-model SDLC / Agile methodologies 21 CFR Part 11 / EU Annex 11 / WHO / PIC/S data integrity guidance Soft Skills & Corporate Traits: Strong leadership and coordination skills for multi-site operations Excellent documentation, audit readiness, and training capabilities Capability to represent the organization in global audits and customer discussions Strong cross-functional communication with IT, QA, QC, Regulatory, and external vendors

About AmpleLogic!! We're a trusted provider of GAMP solutions, specializing in empowering the life sciences industry through our advanced Application Platform as a Service (aPaaS) platform. Since 2010, AmpleLogic has been dedicated to developing industry-standard solutions that are effective, efficient, and competitive. With over 12 products deployed, including eQMS, LMS, DMS, and more, we have served 100+ life science companies worldwide. Our flagship product, eQMS, reflects our commitment to quality, compliance, and innovation. For more information, please visit: https://amplelogic.com/ About the role: Were seeking a detail-driven with .//. educational background having - - in (), , , . Work location: Hi-tech City, Hyderabad Mode of Job: Work from Office Years of experience: 3-4 Educational qualification: B.Tech/BE/M.Tech Roles and Responsibilities will include: - Review new processes and changes, capture lessons and best practices from audited projects to suggest process improvements at the organisational level and implement new processes as per process and change improvements received from employees. Ensure all project documentation is available in, create process-related documentation, maintain audit records in, and perform documentation reviews as per standards Conduct deliverable audits, baseline audits, internal quality audits, and external audit assessments, facilitate closure of audit/assessment findings, and complete assessments of internal LMS on time Handle QA roles for at least 10 projects within 5 months, complete induction and role-specific training as per schedules, and take feedback to improve the induction training mechanism Control code release mechanisms, manage temporary roles for closing pending action items on behalf of exited employees, and ensure action items entry for recording of actual time spent in carrying out of project activities Ensure the final product meets the company's quality standards as a quality assurance executive Ensure compliance of our software is up to date, follow proper escalation and notification mechanisms to address issues, and respond to issues related to software/LMS posted by users on a priority basis Create forms and make changes existing forms and workflows, and provide support as required Create employee profiles in application and LMS tools, and perform user mapping Stabilise processes according to the SDLC delivery model followed in the organisation Make policies updated as per the latest practices followed within the premises, and schedule training to ensure compliance.

Summary: Experienced Team member to handle Instrumentation & Automation (I&A) function in Drug Substance manufacturing plant. This role plays a critical part in ensuring the smooth operation, efficiency, and regulatory compliance of our biopharmaceutical manufacturing processes. To join a team of technicians responsible for maintaining, troubleshooting, and optimizing a complex network of instrumentation and automation systems. Responsibilities: Implement strategies for the preventative maintenance of all I&A equipment within the Drug Substance manufacturing area. Perform qualification of I&A equipment according to cGMP and regulatory requirements. Troubleshoot and resolve I&A system malfunctions, ensuring minimal disruption to production timelines. Work collaboratively with other engineering personnel, production teams and quality assurance to identify opportunities for process optimization through automation. Stay current on advancements in I&A technology relevant to biopharmaceutical manufacturing. Manage and maintain technical documentation for all I&A systems. Prepare and participate in audits and inspections related to I&A systems. Ensure adherence to all safety regulations and procedures within the manufacturing plant. Qualification Bachelor's degree in Engineering (in instrumentation/electronics & communication/ electrical/Computer Science) or a related field. Minimum 5 years of experience in a biopharmaceutical or similar aseptic manufacturing environment with a focus on I&A. Proven experience in a technical environment. Strong understanding of cGMP regulations and GAMP® 5 guidelines. In-depth knowledge of biopharmaceutical manufacturing processes and equipment. Experience with common biopharmaceutical manufacturing automation systems (e.g., DCS, SCADA, PLC). Troubleshooting and problem-solving skills. Strong communication, interpersonal, and collaboration skills. Ability to prioritize and handle multiple tasks in a fast-paced environment. Additional Information About the Department Biologics Currently operates in the Global Biosimilars business - a segment that is poised for attractive and sustained growth over the next 10–15-year time horizon. With a robust portfolio of biosimilar products across key therapeutic areas, covering ~US$80+ Bn in innovator sales – future business pipeline covers a variety of product classes and therapy areas, and new modalities. Fully integrated organization with over two decades of experience in developing, manufacturing and commercializing multiple biosimilar products. With a Product Development engine that has end-to-end capabilities – in-house clone development, upstream and downstream process development, bioanalytical development and proprietary formulation. Supported by a Clinical and Regulatory team with experience in executing complex biosimilar programs with innovative global trial designs. We have a proven experience in commercial-scale manufacturing across a variety of technology platforms with global quality standards and a highly competitive cost structure Rich experience of commercializing high-quality biosimilars in multiple markets with over 900,000 patients having benefited from our products till date. Benefits Offered At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs. The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself. Our Work Culture Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic. For more details, please visit our career website at https://careers.drreddys.com/#!/

About the Role: Grade Level (for internal use): 08 The Role Implementation Engineer The Team The Portfolio Analytics (PA) Application Support team is responsible for onboarding and supporting clients on the Capital IQ platform. Historically focused on manual ingestion workflows and reactive troubleshooting, the team is now evolving to take on a more technical, proactive, and scalable approach. This role will be key in driving that transformation building automation, scripting ingestion processes, and supporting API-based integrations. The Impact This is not just another support role. You will be part of the teams next chapter helping shift from manual operations to automated, scalable solutions . Your technical contributions will improve the client onboarding experience, reduce turnaround time, enhance data accuracy, and free up the team to focus on more strategic tasks. Youll work across client use cases, internal tooling, and automation pipelines directly shaping the future of support within Portfolio Analytics. Responsibilities Support client onboarding by implementing batch ingestion jobs and API integrations Develop and maintain Python scripts for data preprocessing and validation workflows Help automate recurring ingestion tasks , moving away from manual interventions Troubleshoot ingestion or integration issues by working across data, scripts, and scheduling systems Build internal tools and reusable components to support ingestion and workflow scalability Collaborate with Product and Engineering on testing and deploying new ingestion features Maintain technical documentation to standardize and scale implementation support Partner with client-facing teams to deeply understand use cases and deliver technical solutions What Were Looking For 02 years of experience in a technical role (support, implementation, automation, or scripting) Proficiency or strong familiarity with Python and basic scripting logic Understanding of REST APIs and data formats such as JSON, CSV, Excel Exposure to SQL or file-based data manipulation tools (e.g., pandas, shell scripts) Interest in solving operational problems through automation and process improvement Ability to learn financial data structures such as portfolios, benchmarks, and securities Strong analytical and troubleshooting skills, with excellent attention to detail Bachelors degree in Computer Science, Engineering, or a related discipline Why This Role Matters Now As we scale Portfolio Analytics across a growing client base, ingestion and automation will be at the core of our success. This role is an opportunity to join that journey early helping redefine how support is delivered and building the technical foundation for what comes next. About S&P Global Market Intelligence At S&P Global Market Intelligence, a division of S&P Global we understand the importance of accurate, deep and insightful information. Our team of experts delivers unrivaled insights and leading data and technology solutions, partnering with customers to expand their perspective, operate with confidence, andmake decisions with conviction.For more information, visit www.spglobal.com/marketintelligence . Whats In It For You Our Purpose: Progress is not a self-starter. It requires a catalyst to be set in motion. Information, imagination, people, technologythe right combination can unlock possibility and change the world.Our world is in transition and getting more complex by the day. We push past expected observations and seek out new levels of understanding so that we can help companies, governments and individuals make an impact on tomorrow. At S&P Global we transform data into Essential Intelligence, pinpointing risks and opening possibilities. We Accelerate Progress. Our People: Our Values: Integrity, Discovery, Partnership At S&P Global, we focus on Powering Global Markets. Throughout our history, the world's leading organizations have relied on us for the Essential Intelligence they need to make confident decisions about the road ahead. We start with a foundation of integrity in all we do, bring a spirit of discovery to our work, and collaborate in close partnership with each other and our customers to achieve shared goals. Benefits: We take care of you, so you cantake care of business. We care about our people. Thats why we provide everything youand your careerneed to thrive at S&P Global. Health & WellnessHealth care coverage designed for the mind and body. Continuous LearningAccess a wealth of resources to grow your career and learn valuable new skills. Invest in Your FutureSecure your financial future through competitive pay, retirement planning, a continuing education program with a company-matched student loan contribution, and financial wellness programs. Family Friendly PerksIts not just about you. S&P Global has perks for your partners and little ones, too, with some best-in class benefits for families. Beyond the BasicsFrom retail discounts to referral incentive awardssmall perks can make a big difference. For more information on benefits by country visithttps://spgbenefits.com/benefit-summaries Global Hiring and Opportunity at S&P Global: At S&P Global, we are committed to fostering a connected andengaged workplace where all individuals have access to opportunities based on their skills, experience, and contributions. Our hiring practices emphasize fairness, transparency, and merit, ensuring that we attract and retain top talent. By valuing different perspectives and promoting a culture of respect and collaboration, we drive innovation and power global markets. Recruitment Fraud Alert If you receive an email from a spglobalind.com domain or any other regionally based domains, it is a scam and should be reported to reportfraud@spglobal.com. S&P Global never requires any candidate to pay money for job applications, interviews, offer letters, pre-employment training or for equipment/delivery of equipment. Stay informed and protect yourself from recruitment fraud by reviewing our guidelines, fraudulent domains, and how to report suspicious activity here. ----------------------------------------------------------- Equal Opportunity Employer S&P Global is an equal opportunity employer and all qualified candidates will receive consideration for employment without regard to race/ethnicity, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, marital status, military veteran status, unemployment status, or any other status protected by law. Only electronic job submissions will be considered for employment. If you need an accommodation during the application process due to a disability, please send an email to EEO.Compliance@spglobal.com and your request will be forwarded to the appropriate person. US Candidates Only The EEO is the Law Poster http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf describes discrimination protections under federal law. Pay Transparency Nondiscrimination Provision - https://www.dol.gov/sites/dolgov/files/ofccp/pdf/pay-transp_%20English_formattedESQA508c.pdf ----------------------------------------------------------- 20 - Professional (EEO-2 Job Categories-United States of America), IFTECH203 - Entry Professional (EEO Job Group), SWP Priority Ratings - (Strategic Workforce Planning)

Expertise in computer system validation, QMS and IT Compliance. Good understanding of GAMP 5, 21 CFR Part 11, Annex 11, ICH Q9. QMS: Initiation/Review of change management, Investigation, CAPA, Deviation etc. WFO, Mumbai - Immediate - 15 Days

We are looking for a skilled CSV Lead with 15-25 years of experience to join our team at IDESLABS PRIVATE LIMITED. The ideal candidate will have a strong background in CSV and excellent leadership skills. Roles and Responsibility Lead the development and implementation of CSV strategies to ensure compliance with regulatory requirements. Collaborate with cross-functional teams to identify and mitigate risks associated with CSV. Develop and maintain relationships with key stakeholders, including regulators and industry partners. Provide training and guidance on CSV best practices to team members. Conduct audits and assessments to ensure adherence to CSV standards. Develop and implement process improvements to enhance CSV efficiency and effectiveness. Job Requirements Strong knowledge of CSV principles and regulations, including FDA guidelines. Excellent leadership and communication skills, with the ability to motivate and guide team members. Experience working in a fast-paced environment with multiple priorities and deadlines. Strong analytical and problem-solving skills, with attention to detail and the ability to identify risks. Ability to work collaboratively with cross-functional teams, including sales, marketing, and engineering. Strong understanding of quality management systems and ISO standards. Location- Bengaluru,Chandigarh,Dadra & Nagar Haveli,Daman,Diu,Goa,Haveli, Jammu, Lakshadweep, Nagar,New Delhi,Puducherry,Sikkim

Educational Master Of Technology,Bachelor Of Science,Bachelor Of Technology,Bachelor of Engineering,Bachelor of Pharmacy (Honors),Master of Pharmacy 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, PQ’s, 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 areasoIT QMSoValidation/QualificationoRisk management. oHandling of defects/Deviations oInvestigations oCAPA Handling oTest 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 : 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)