150 Gxp Jobs - Page 3

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 Description: GxP Expertise: Conduct GxP compliance assessments for SAP systems and processes. Develop and implement GxP validation plans for SAP modules within supply chain, quality management, and manufacturing. Ensure documentation and procedures meet GxP requirements Prepare all the GxP Documentation and Protocols Execute all the GxP Protocols Validation and Compliance: Participate in the validation of SAP systems and processes for GxP compliance. Prepare and manage validation documentation (plans, reports, etc.). Liaise with regulatory agencies during inspections and audits. Stay updated on evolving GxP regulations and industry best practices. Preferred candidate profile Bachelor's degree in Life Sciences, Engineering, or related field. Minimum 3 years of experience in the pharmaceutical industry. Demonstrated expertise in SAP (S/4HANA preferred), particularly modules related to Supply Chain Management, Quality Management, and Manufacturing. In-depth knowledge of GxP regulations (FDA, cGMP, etc.). Strong validation and compliance expertise. Ability to work independently and as part of a team.

Project Role : Application Lead Project Role Description : Lead the effort to design, build and configure applications, acting as the primary point of contact. Must have skills : Manufacturing Engineering MES Good to have skills : NAMinimum 7.5 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Application Lead, you will lead the effort to design, build, and configure applications, acting as the primary point of contact. Your typical day will involve collaborating with various teams to ensure that application development aligns with business objectives, overseeing project timelines, and facilitating communication among stakeholders to drive successful project outcomes. You will also engage in problem-solving activities, providing guidance and support to your team while ensuring that best practices are followed throughout the development process. Roles & Responsibilities:Must Have experience in managing Teams/projects for Pharmasuite installation, recipe authoring, validation etcCoordination with multiple internal and external stake holdersExperience in driving delivery in Life science industry and release management.Must have understanding of CSV and GxP(GDP, GMP,GCP etc).Must show ability to create conceptual and detailed designs of MES Global templateProvide design guidance to developers and testers as an integrated part of an agile scrum processMust show competence in ability to problem solve and work through complex situationsMust be able to configure and deploy MES software applications and systemsAbility to support, maintain, and enhance deployed software solutions Professional & Technical Skills: - Must To Have Skills: Rockwell Pharmasuite, CSV, GxP compliance, Life Sciences, Pharma Manufacturing-Good to Have Skills: VB .NET, PL/SQL- Knowledge about shop floor functional processes & Industry standards (ISA95/88), CFR 21 Part 11- Knowledge of MES (Manufacturing Execution System) & MO (Manufacturing Operations) concepts and systems- Must have Knowledge in Rockwell Pharmasuite Installation/Upgrade and Modules like manufacturing, Packaging, Quality, Warehouse & Material flow, Equipment Management, Formulas, Dispensing, Access management, Data Transfer, Barcodes, configuration & customization.- Should have worked as architect and must have experience of end to end implementation right from requirement analysis, mapping these to technical design, development, testing and deployment- Design & development of interfaces between MES and ERP (ERP Integration) and shop floor systems (e.g OPC) integration Additional Information:- The candidate should have minimum 7.5 years of experience in Manufacturing Engineering MES.- This position is based at our Bengaluru office.- A 15 years full time education is required.- Ability to build from good relationships with clients/operational managers and colleagues- Outstanding all-round communication skills and ability to work collaboratively- Good Team management skills and work closely with other peers Qualification 15 years full time education

Perform manual testing of applications in GxP-regulated environments (GMP, GLP, GCP). Review and understand User Requirements Specifications (URS) and Functional Specifications (FS) . Design and execute test cases , test scripts , and test data based on regulatory and business requirements. Ensure all testing activities comply with 21 CFR Part 11 , Annex 11 , and ALCOA+ principles. Maintain comprehensive test documentation , including traceability matrices , test summary reports , and deviation logs . Participate in validation activities including IQ, OQ, and PQ phases. Collaborate with QA, business analysts, and development teams to ensure audit readiness . Support internal and external audits by providing required documentation and evidence. Required Skills: 4+ years of experience in manual testing with at least 2 years in GxP-compliant environments . Strong understanding of GMP, GLP, GCP , and CSV (Computer System Validation) . Experience with test management tools (e.g., HP ALM, Jira, TestRail). Familiarity with 21 CFR Part 11 , Annex 11 , and data integrity standards. Excellent documentation and communication skills. Ability to work in a regulated, process-driven environment .

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

We are seeking a highly motivated Support Analyst to provide application administration, user support, and issue resolution for computer systems used across Early Development. This role acts as a technical liaison between IT and end users, ensuring optimal system performance and compliance with regulatory standards. Key Responsibilities: Act as SME for assigned applicationssupporting users, troubleshooting issues, and managing system documentation. Handle user access control, perform audits, and maintain compliance documentation (GLP/SOP). Coordinate application deployments, upgrades, validations, and decommissioning. Collaborate with stakeholders to optimize business processes and system functionality. Maintain and review system SOPs, user manuals, and ensure audit readiness. Liaise with IT and vendors to resolve technical escalations and system configurations. Must-Have Qualifications: 2-3 years of relevant support or application administration experience Strong skills in MS Excel, MS Word, and business/technical applications Understanding of GxP, GLP, regulatory environments, and computer validation principles Bachelor's degree (or equivalent experience) Preferred Skills: Familiarity with NG/Pristima, Tox Reporting tools Experience supporting lab-based systems or instruments Knowledge in small project management and release control

Role: Support Analyst / Application Administrator We are seeking a highly motivated Support Analyst to provide application administration, user support, and issue resolution for computer systems used across Early Development. This role acts as a technical liaison between IT and end users, ensuring optimal system performance and compliance with regulatory standards. Key Responsibilities: Act as SME for assigned applicationssupporting users, troubleshooting issues, and managing system documentation. Handle user access control, perform audits, and maintain compliance documentation (GLP/SOP). Coordinate application deployments, upgrades, validations, and decommissioning. Collaborate with stakeholders to optimize business processes and system functionality. Maintain and review system SOPs, user manuals, and ensure audit readiness. Liaise with IT and vendors to resolve technical escalations and system configurations. Must-Have Qualifications: 23 years of relevant support or application administration experience Strong skills in MS Excel, MS Word, and business/technical applications Understanding of GxP, GLP, regulatory environments, and computer validation principles Bachelor's degree (or equivalent experience) Preferred Skills: Familiarity with NG/Pristima, Tox Reporting tools Experience supporting lab-based systems or instruments Knowledge in small project management and release control

We are seeking a highly motivated Support Analyst to provide application administration, user support, and issue resolution for computer systems used across Early Development. This role acts as a technical liaison between IT and end users, ensuring optimal system performance and compliance with regulatory standards. Key Responsibilities: Act as SME for assigned applicationssupporting users, troubleshooting issues, and managing system documentation. Handle user access control, perform audits, and maintain compliance documentation (GLP/SOP). Coordinate application deployments, upgrades, validations, and decommissioning. Collaborate with stakeholders to optimize business processes and system functionality. Maintain and review system SOPs, user manuals, and ensure audit readiness. Liaise with IT and vendors to resolve technical escalations and system configurations. Must-Have Qualifications: 23 years of relevant support or application administration experience Strong skills in MS Excel, MS Word, and business/technical applications Understanding of GxP, GLP, regulatory environments, and computer validation principles Bachelor's degree (or equivalent experience) Preferred Skills: Familiarity with NG/Pristima, Tox Reporting tools Experience supporting lab-based systems or instruments Knowledge in small project management and release control

We are seeking a highly motivated Support Analyst to provide application administration, user support, and issue resolution for computer systems used across Early Development. This role acts as a technical liaison between IT and end users, ensuring optimal system performance and compliance with regulatory standards. Key Responsibilities: Act as SME for assigned applicationssupporting users, troubleshooting issues, and managing system documentation. Handle user access control, perform audits, and maintain compliance documentation (GLP/SOP). Coordinate application deployments, upgrades, validations, and decommissioning. Collaborate with stakeholders to optimize business processes and system functionality. Maintain and review system SOPs, user manuals, and ensure audit readiness. Liaise with IT and vendors to resolve technical escalations and system configurations. Must-Have Qualifications: 2-3 years of relevant support or application administration experience Strong skills in MS Excel, MS Word, and business/technical applications Understanding of GxP, GLP, regulatory environments, and computer validation principles Bachelor's degree (or equivalent experience) Preferred Skills: Familiarity with NG/Pristima, Tox Reporting tools Experience supporting lab-based systems or instruments Knowledge in small project management and release control #SupportAnalyst #ApplicationAdmin #ITSupport #HiringNow #GLPCompliance #ApplicationSupport #HealthcareIT #RemoteJobs #ContractJobs #SOP #SystemValidation #ITJobsIndia #ResumeCall #SuzvaHiring

(A) RESPONSIBILITIES : 1.) PROJECTS: Budgeting, Technical Detailing, Planning & Execution for Dahej Plant. Design, Coordinate and implement the systems, as per the standards defined for Dahej. Capex & Revenue Budget preparation for Dahej plant. Monitoring End User's support at Dahej Plant. Review all assets (physical and records) on a regular basis. Ensure records of analytical Systems connected to Analytical servers are also kept up to date on a regular basis. Handling of Infrastructure Maintenance, IT Consumables, repairs & Inventory at Dahej Location. 2.) GMP/GLP COMPLIANCE: Prepare and maintain compliance document for production and QC production equipment / system. Prepare SOP, Protocol for New or Existing IT production system. Perform Backup and restoration study for QC and Production System, MES, LMS, Packing, Track and trace system infra implementation and qualification. Responsible for creating awareness of GMP/GLP policy to all subordinates. 3.) ONGOING ACTIVITIES: Monitoring AMC services at Dahej for all IT related Services. Monitoring Disaster. Recovery & Back up Management. Coordinate with Vendors for communication links. Adhere to all Policies as defined from time to time. Ensure the performance of the IT infrastructure at Dahej Plant. Support and directly be responsible for all the Infrastructure management at Dahej location. Support all the GMP, GLP and other Audit requirements at Dahej from IT infrastructure perspective. Responsible for updating annexure of all SOPs on a regular basis as mentioned in the SOP. MES, LMS system User Management and Technical support. 4.) SERVERS: Server policy implementation, documentation & technical up gradation. 5.) OTHERS: Support to software's (QC, Packing & HR) & coordinating with HO for in house developments. Responsible for creating awareness of ISO 14001, OHSAS 18000 and HSE policy to all subordinates. Responsible to seek participation of employees to achieve HSE policy. Waste reduction in all areas wherever possible. (B) AUTHORITY (APPLICABLE ON HOD) : IT super admin for all GXP applications. Authorised signatory for IT SOP's. (C) DELEGATION OF RESPONSIBILITY (APPLICABLE TO HOD) : In case of leave/absence part responsibility can be delegated to Assistant Manager - IT. (D) DELEGATION OF AUTHORITY (APPLICABLE TO HOD) : In case of leave/absence part authority can be delegated to Assistant Manager - IT. QUALIFICATION: B.E. or relevant qualification related to IT. EXPERIENCE: 14 to 20+ Years DESIGNATION: Manager LOCATION: Dahej, Gujarat PREFERRED CANDIDATE PROFILE: Candidate should have in depth experience of the IT field in Pharmaceutical industry is compulsory.

Dear Candidate, Greetings of the day! We are hiring for the position of Cluster Head IT (GM) for Aurangabad location. Company Profile: Harman Finochem Limited leading India-based pharmaceutical company which was established by Late Mr. Bhupinder Singh Manhas in 1983. It specializes in the manufacture and export of more than 45 Active Pharmaceutical Ingredients (APIs) of which 10 are Essential drugs as per the WHO model list. Company has its Head office at Kalina, Santacruz (East), Mumbai and 3 state-of-the-art API manufacturing facilities and one formulation manufacturing site at Aurangabad that have been inspected by USFDA. Role & responsibilities : Establishing organizational technology vision and goals. Establishing and enforcing IT guidelines, policy, and standards and managing IT budget. Evaluate Business Needs, Study IT systems to evaluate effectiveness, and make recommendations for improvement and appropriate IT Solutions. Studying current and new pharma industry trends, technologies, and software development. Strategizing and implementing technology that results in company growth. Estimating and establishing cost parameters, budgets, and potential ROI. Collaborating with the leadership team to create long-term plans and improvements. Providing support and mentorship to IT team members. Creating and customizing technology systems for optimized performance. Sourcing and Buying technology software, equipment, and accessories for the company by selecting the right suitable vendors. Implementing technology to streamline internal operations and optimize strategic benefits. Ensuring the company's technological processes and services comply with all requirements, laws, and regulations. Evaluate Best Practices and Implement the Same Wherever Necessary. Periodical Evaluation of Controls and tightening / implementation of the same. Effective MIS Generation with Minimum Effort and Duplication of Effort. SAP S4hana 1909 ERP Package gap implementation, and improvements along with support the existing process. Support Factories and other locations for smooth IT Operations. Hardware Procurement & Maintenance. Software procurement, development and implementation. Vendor Development. LAN / WAN uptime. (Cisco Meraki Solution) Support Internet and Email for all locations. Audit Management (USFDA , EUGMP, MHRA, Vendor) Support IT CSV & CSA activities. Implement & Manage Data Security & Cyber security. Preferred candidate profile : Expertise requires - SAP S4Hana, All Lab solution applications and IT Infrastructure & Security. Experience :18-25 Years in Pharma API / Formulation Manufacturing Industry. Team Management of 20+ team members across all locations. Perks and benefits : As per Industry Standard Interested candidates can share their profiles at poonamm@harmanfinochem.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)

Cloud Architect with 5-10 yrs exp. in Azure AD IAM, PIM/JiT, IaC (Bicep/Terraform), and cloud security. Lead IAM design, optimize AAD, integrate DevOps, ensure compliance, support teams, and stay ahead of trends. Pharma/GxP & SAFe a plus.

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

Hi, Wishes from GSN!!! Pleasure connecting with you!!! We been into Corporate Search Services for Identifying & Bringing in Stellar Talented Professionals for our reputed IT / Non-IT clients in India. We have been successfully providing results to various potential needs of our clients for the last 20 years. At present, GSN is hiring Business Analyst - LIFE SCIENCE for one of our leading MNC client. PFB the details for your better understanding : 1. WORK LOCATION : Chennai 2. Job Role: Business Analyst 3. EXPERIENCE : 7 to 15 yrs 4. CTC Range: Rs. 15 to Rs. 25 LPA 5. Work Type : WFO ****** Looking for SHORT JOINERS ****** Job Description : 7+ years of relevant experience in Business Analysis preferably from life science domain • Strong knowledge and application of business analysis principles. • Strong business analysis skills used to document user requirements. • Strong and effective time management skills. • Strong business analysis skills used to document user requirements. • Ability to stay up to date on complex new applications, processes, and procedures. • Strong ability to prioritize and manage projects/task simultaneously Note : kindly go through GOOGLE reviews on www.gsnhr.net Kindly feel free to contact us for any queries. Thanks & Regards YOGI GSN CONSULTING 9840074801 Email : yogi@gsnhr.net; Web : www.gsnhr.net/ https://g.co/kgs/UAsF9W

Context Sanofi strategic direction is to standardize processes across sites, to embrace the digital transformation of its Manufacturing & Supply perimeter, looking at the opportunity to simplify its current solution landscape and leverage advanced technologies to bring business value In that context, the MARS program aims to implement the Computer-assisted batch review, enabled by the definition and roll-out of a core Manufacturing Execution System (MES) The MARS (MES Accelerated Roadmap @ Sanofi) program will transform Sanofi plants, improving compliance, cost and cycle time performance Over the last 3 years, Sanofi has deployed 30 Production sites across 4 GBUs (multiple and different pharmaceutical processes, 18 Weighing & Dispensing & 12 full MES), and a second wave, should start in the coming years (> 50 production sites, pending business case confirmation) This represents a strategic opportunity for an Manufacturing & Supply Transformation to: Design standardized end-to-end processes to generate business value for Manufacturing & Supply and deliver best-in-class solutions to our industrial sites, with a high focus on electronic batch record management (content, execution) & review by exception process; Deliver innovative "state of the art" tools enabling performance for manufacturing processes across the industrial affair sites; Allow new generation of deployment more Agile & business centric Maintain robust and highly available solutions to operate industrial processes efficiently About The Job The Digital MES Deployment & Integration Expert ensures the optimal performance of MES systems and Platforms by delivering solutions tailored to business needs This role plays a central part in the deployment and evolution of Sanofis MES Core Model across industrial sites Main Responsibilities End to end responsibility to install, configure, and update Industrial sites MES Digital systems and Platforms Provide high-level of support, coordination, and communication to Industrial sites projects, maintain documentation, and drive continuous improvement Contribute to the evolution towards an innovative MES Standard by leveraging AI, Cloud services and DevOps tools Optimize MES performance and monitoring through development and automation initiatives Occasionally, it may be required to perform the installations / updates over the weekend depending on the industrial site requirements Share knowledge and foster digital skills development within the MES domain This cross-functional role involves close collaboration with industrial sites, digital teams, infrastructure, cybersecurity, and external partners The expert stays up to date with internal standards, industry best practices, and emerging technologies, while also contributing to the optimization of digital maintenance processes and tools MES Scope MES Solutions Siemens MES Opcenter Execution Pharma Product Koerber MES PAS-X Product Technical landscape: Cloud technologies & DevOps tools Kubernetes Windows Server Oracle Prostgre SQL CitrixAzure services Ansible Mendix C# Power-shell VB PL/SQL End-to-end pharmaceutical manufacturing process Production & Work Instruction Execution Traceability & Genealogy Weighing & Dispensing Integration with ERP, SCADA, LIMS, WMS, Labeling, OEE, Data Platforms Recipe & Batch Management Quality Control & Compliance (GxP) Real-time Monitoring & Performance Tracking Automation & Digital Maintenance Support Experience About you 5+ years of experience in the Digital Manufacturing Execution System (MES) domain within the pharmaceutical industry, with a strong interest in upskilling on emerging technologies and enhancing MES technical capabilities and Industrialization, or 5+ years of experience with Cloud technologies and DevOps tools, driving automation, scalability, and system reliability/Industrialization, with a strong interest in upskilling in the functional MES domain Soft Skills Strong focus on value delivery, with the ability to work autonomously on solution design and take ownership and leadership within the assigned scope Proven ability to work effectively in large-scale multicultural, multilingual, and matrixed organizational environments Solid understanding of manufacturing processes in pharmaceutical plants, with strong knowledge of GxP regulations Agile methodology practitioner Knowledge of reporting tools (Power BI) MES Solutions Technical Skills Siemens MES Opcenter Execution Pharma MES Product Koerber MES PAS-X MES Product Cloud technologies & DevOps tools Kubernetes Windows Server Oracle Prostgre SQL CitrixAzure services Ansible Mendix C# Power-shell VB PL/SQL Education: Engineering or Masters in Computer Science or related field (or equivalent experience) Languages: English Pursue progress, discover extraordinary Better is out there Better medications, better outcomes, better science But progress doesnt happen without people people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen So, lets be those people At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi com! null

We are looking for a highly skilled and experienced professional to join our team as a Manager - Sample Collection at Vijaya Diagnostic Centre. The ideal candidate will have a strong background in healthcare, with excellent leadership and management skills. Roles and Responsibility Manage and supervise the sample collection team for efficient operations. Develop and implement effective strategies for improving sample quality and reducing errors. Collaborate with other departments to ensure seamless communication and coordination. Analyze data and metrics to identify areas for improvement and optimize processes. Ensure compliance with regulatory requirements and industry standards. Train and mentor new team members to enhance their skills and knowledge. Job Requirements Minimum 5 years of experience in a similar role, preferably in healthcare or a related field. Strong knowledge of laboratory procedures and protocols. Excellent leadership, communication, and interpersonal skills. Ability to work in a fast-paced environment and meet deadlines. Strong analytical and problem-solving skills with attention to detail. Familiarity with quality control measures and quality assurance procedures.

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)

Educational Bachelor of Engineering Service Line Enterprise Package Application Services Responsibilities Lead the engagement efforts at different stages from problem definition to diagnosis to solution design, development & deployment, contribute to unit level & organizational initiatives Worked as Subject Matter Expert in SD area Experience as a Solution Architect in Logistics, Functional Lead in SD with experience in implementation, Logistics solution (Conducting workshops, Design, Testing, Data Migration and hyper care cutover activities) Strong knowledge of Sales Process, Intercompany transaction, 3PL Logistics, Toll Manufacturing transactions / business processes and best practices Exposure to other Logistics area like Procurement, Warehouse Management, Transport Management etc. Additional Responsibilities: SAP SD / O2C / Logistics with Pharma Industry experience. The candidate is expected to be a senior Functional Architect for SAP Programs and should possess broad functional knowledge in Logistics domain and in-depth technical knowledge in the SAP SD module. Also, should have proven expertise in Designing, configuring and supporting SAP landscapes. Proactive approach to problem solving. Experience in working in Global delivery model will be an added advantage. Excellent team management skill High analytical skills A high degree of initiative and flexibility High customer orientation & quality awareness Domain experience in Logistics areas of life science industry or SAP SD S/4HANA certification with professional level (preferred). Technical and Professional : Minimum 15 years of SAP SD experience and should have at least two end to end implementation projects in S/4HANA Experience as Solution Architect in the above programs. Good Knowledge in integration aspects with other modules MM, WM and SD Expertise in S/4HANA simplifications in logistics areas. Deep Knowledge and expertise in Logistics BPML with an ability to guide clients to Industry Best practices. Experience in driving Business process workshops and Fit / GAP analysis Ability to understand business requirements from business users and prepare requirement document, functional specifications. Good understanding of GXP and SOX requirements. Should have working experience in a highly regulated environment. Should be aware of release governance processes and have experience in working on any incident management tool. Handled post go live critical issue resolving till stabilization. Preferred Skills: Technology-SAP Functional-SAP SD Technology-SAP Functional-S4 HANA - Logistics

Educational Bachelor of Engineering Service Line Enterprise Package Application Services Responsibilities As a Solution Architect, lead the engagement efforts at different stages from problem definition to diagnosis to solution design, development & deployment in large S/4 HANA transformation programs Create detailed design and architecture, and process artifacts, implement the solution and the deployment plan Connect with senior client business and IT stakeholders, demonstrating thought leadership in domain, process, and technology Contribute to Unit and Organizational initiatives and COEs Additional Responsibilities: SAP FICO / R2R with experience in any of the following industry (Pharma, Professional Services, Utility, Telecom, Oil and Gas/Public sector/Resources). The candidate is expected to play the role of an expert level Functional Solution Architect in large SAP transformation programs. The candidate should possess strong domain knowledge in Finance and should be experienced and adept at S/4 HANA SAP FICO module with hands-on expertise. S4 HANA Public Cloud module with hands-on expertise is an added advantage. Proactive approach to problem solving. Good understanding of GXP and SOX requirements Experience in working in Global delivery model will be an added advantage. Excellent team management skill High analytical skills A high degree of initiative and flexibility High customer orientation High quality awareness Technical and Professional : 15+ years of relevant SAP & domain experience Strong hands-on and in-depth knowledge of S/4 HANA FICO module Strong understanding of the Financial Accounting processes coupled with exposure to various P2P, O2C, M2D process scenarios, expertise in EBRR, Planning, FP&A & good understanding of taxation procedures, the relevant accounting treatment and the statutory compliance as per applicable Accounting Principles Thorough understanding of Agile and Activate methodologies Should have done at least two end to end implementation projects in S/4HANA as a Lead Functional Solution Architect Deep Knowledge and expertise in Finance BPML with an ability to guide clients to Industry Best practices Experience in leading and driving Business process workshops and Fit/GAP analysis Preferred Skills: Technology-SAP Functional-SAP Controlling Technology-SAP Functional-SAP Finance Technology-SAP Technical-SAP HANA

Key requirements for this role are as follows: Excellent Communication skills Stakeholder comms Progress updates Comms related to Risk/Issue Outstanding Planning skills (using Agile/SAFe) Scope Clarity and Goal Setting Art of breaking down the work Estimation Work Allocation Risk and Dependency Management Strong Tracking and Monitoring Tracking progress Identifying and Raising Risks Behaviours Accountability/Ownership demonstrated Ability to work cohesively with people/teams Domain Should have preferably worked in Capital Markets Mandatory Competencies Agile - Agile FS Domain - Capital Market Beh - Communication

Immediate Openings on CSV Analyst _Bangalore Experience : 5+ Skill:- CSV Analyst Location : Bangalore Notice Period :- Immediate . Employment Type: Contract . Job Description: Key Skills: - Application/Product development testing and experience in Computer Systems Validation (CSV) - Experience in QMS, Regulatory Requirements, GxP Compliance, and Good Documentation Practices - Strictly adhereing to Business SOPs, cost & coverage, requirement specifications & formulation of Test Cases in HP ALM for the Functional, Integration, end-to-end, Usability, and smoke testing. - Experience in the development of Qualification test scripts (IQ,OQ, PQ and VSR) for CSV projects - Good knowledge of CSV, GAMP5, 21CFR Part 11, and good documentation practices - Knowledge on HP ALM and Jira Tool and validation approval process using ALM

: GxP Manual Functional TesterMinimum 4+ years of experience in manual testing in GxP-compliant environments Good understanding of STLC, Functional testing, FIT, UAT, Defect Management Hands on experience in FIT Test case design and executions Hands on experience in UAT test design Working experience with Agile Incremental testing Experience with test management tools (Jira) Understanding of SDLC and Agile methodologies Good communication and documentation skills Collaborate with business, development, and regulatory teams Track and report defects using Jira or similar tools Emailanusha.r@ideslabs.com Location - Chandigarh,Dadra & Nagar Haveli,Daman,Diu,Goa,Haveli,Hyderabad,Jammu,Lakshadweep,Nagar,New Delhi,Puducherry,Sikkim

You will be part of a highly motivated, collaborative, and diverse Computer Software Assurance / Validation Team. Job description: Bachelor of Science or equivalent in computer science, engineering, life sciences, or related field Minimum 3+ years experience in IT & Software Validation (CSV/CSA, GAMP) Good knowledge of Food and Drug Administration regulations/guidance (i.e. CFR 21 FDA Part 11, Annex 11, EU GMP Annex 1, GxP practices) Good understanding of system and data risk assessment General understanding of Agile Methodology(Framework (i.e. SAFe, Scrum), previous experience would be an advantage. Ability to work collaboratively in cross-functional and agile teams to achieve milestones and goals Effective communicator with excellent verbal and written communication skills - English language mandatory Assertiveness and ability to work with diverse personalities/cultures Lets find out what a usual day of work might look like. You will: Determine validation approaches, and identifies deliverables needed or impacted by a project / enhancement / change for GxP computerized systems Be responsible for the review of system documentation according to the Roche CSV SOPs and regulatory guidance Develop validation plans/reports, reviews test plans/reports (and other deliverables), and assess, authorize, and notify that the system is ready to go live Verify testing plans, activities, deliverables, and records, provide consultancy on test-related deviations and corrective actions according to approved procedures Support in deviation investigations to identify root causes and define corrective and/or preventative actions Support system audit/inspection preparation and execution as CSV subject matter expert Support system maintenance and enhancement activities, ensuring the validated state is kept, and it is audit and inspection ready Support system periodic reviews according to company procedure We offer: dedicated training budgets and many opportunities for personal and professional self-development (training, conferences, diversified career paths, etc.) a workplace that supports innovation and new ideas attractive benefits & business travel opportunities work in a great team with international colleagues on exciting topics to shape the IT behind the healthcare of tomorrow