Qualification: MBBS Experience: 1 to 3 years Previous experience in medical review of ICSRs. Knowledge of safety databases, such as Argus, ARISg, or similar systems. Familiarity with medical coding dictionaries (e.g., MedDRA) and adverse event reporting standards (e.g., ICH E2B). Strong attention to detail and ability to work with complex medical data. Effective communication and interpersonal skills to collaborate with cross-functional teams and stakeholders. Key Responsibilities: Individual Case Safety Reports (ICSRs) Review: Conduct thorough and objective medical review of ICSRs received from various sources, including clinical trials, spontaneous reports, and literature. Assess the medical relevance and causality of adverse events reported in ICSRs. Identify and evaluate potential safety signals and perform appropriate follow-up actions as necessary. Ensure accurate and timely reporting of serious and non-serious adverse events to regulatory authorities.

Support in the implementation of a compliant quality management system for Clinical trials. Monitor the quality compliance of Clinical Trials, Bioavailability and Bioequivalence Organization. Compliance review and identifying process improvement/ optimization in Pharmacovigilance (PV) and Clinical operations. Providing support to the Medical Affairs with respect to interpretation of regulatory guidelines. Responsible to feed information into the tracking tool to be able to provide trends on compliance reviews. Assist in preparation, review of standard operating procedures for Clinical Trials, BA/BE and PV Support in quality control reviews of key trial documents (protocols, Informed Consent forms, Clinical Study Reports, Investigator Brochures, and others if requested). Perform quality control review of the PV processes like ICSR, Aggregate report and Signal report. Support in external and internal audit preparation activities during audit. Support in risk management for Medical Affairs function related activities. Support in implementation and ensuring compliance to ISO 27001 and ISO 27701 standards.

Arcolab is looking for a resource in HR Compensation & Benefits. Pls find the JD below. Role Objective To provide comprehensive support to the Sr. Process Lead / Senior Consultant by assisting in both compensation projects and HR consulting projects. The role involves supporting the annual increment process, data cleaning, data management, and generating ad hoc reports for compensation-related activities. Additionally, the Associate will contribute to consulting projects through research, case study preparation, white paper development, and assisting with client presentations. Key Responsibility Areas Compensation Operations Support 1.Annual Increment Process Support 2.Data Management: Maintain compensation data, ensuring all records are up-to-date and stored securely. 3.Ad Hoc Report Generation: Generate ad hoc reports based on client or internal requirements, focusing on compensation trends, salary structures, and benchmarking data. 4.Compensation Benchmarking: Assist in analyzing salary data against market benchmarks and provide insights for compensation adjustments. 5.Salary Survey Participation: Support in the preparation and submission of salary surveys by compiling and cleaning relevant compensation data. 6.Incentive and Benefits Data: Collect and analyze data on incentive programs and benefits packages to support compensation decision-making. 7.Pay Structure Analysis: Assist in reviewing and analyzing pay structures and salary ranges for different roles within client organizations. 8.Compliance Assistance: Help ensure compensation policies and practices comply with relevant local regulations and company policies. HR Consulting Support 11.Project Support: Assist the Senior Consultant in supporting consulting projects by gathering and managing project data and documentation. 12.Presentations Preparation: Create PowerPoint presentations for consulting projects, ensuring clear visualizations of data and insights. 13.Data Management for Consulting Projects: Maintain and organize data related to various HR consulting projects, ensuring accessibility for team members. 14.Research & White Paper Support: Conduct research on HR trends, industry benchmarks, and best practices to support the development of white papers and consulting insights. 15.Case Study Preparation: Assist in preparing client case studies that highlight key findings and outcomes from consulting projects. 16.Client Reports: Help in preparing reports for clients, including summarizing project findings and providing recommendations. 17.Survey Coordination: Support the creation, distribution, and analysis of employee surveys and engagement assessments for client projects. 18.Internal Documentation: Assist in documenting project processes and maintaining records of consulting engagements for future reference. 19.HR Policy Research: Conduct research on HR policies and trends to support consulting recommendations for client organizations. 20.Process Improvement: Identify opportunities for improving efficiency in data management and report generation for both compensation

Implementation of Pharmacopeial Updates and Source Change Document Managing master data operations within the LIMS and SAP system Developing, Optimizing, Validating, Verifying and Method transfer of analytical methods Ensuring discipline in Track Wise by monitoring pending tasks and facilitating the closure of quality events Ensuring adherence to regulations and maintaining the completeness of relevant logbooks or registers Conducting on-the-job training sessions on departmental SOPs to maintain compliance

Arcolab is looking for a Full stack developer, pls find the JD below. Experience: 3+ years of experience as a Full Stack Developer or similar role, with a strong portfolio of web applications. Technical Skills Required : Proficiency in front-end technologies (HTML, CSS, JavaScript, React, Angular, etc.). Proficiency in back-end technologies (Node.js, Flask, Django, FastAPI, Streamlit, etc.). Experience with database management (SQL, NoSQL). Experience with DevOps tools (Docker, Kubernetes, etc.). Experience with cloud platforms (AWS, Azure). Responsibilities: Develop and Maintain Web Applications: Design, develop, and maintain both front-end and back-end components of web applications using open-source technologies. Collaborate with Data Scientists and MLOps Engineers: Work closely with data scientists and MLOps engineers to integrate machine learning models and data pipelines into web applications. DevOps Support: Implement and manage CI/CD pipelines, automate deployment processes, and ensure the scalability and reliability of applications. Database Management: Design and manage databases, ensuring data integrity and performance optimization. API Development: Develop and maintain RESTful APIs to support data integration and application functionality. Performance Optimization: Monitor and optimize application performance, ensuring fast load times and responsiveness. Security: Implement security best practices to protect applications and data. Documentation: Create and maintain technical documentation for application development and deployment processes. Stay Updated: Keep up to date with the latest trends and technologies in web development and DevOps.

Arcolab is looking for Logic App Developer. Pls find the JD below. Design and develop integration workflows using Azure Logic Apps, Azure Functions, Service Bus, and Event Grid. Integrate diverse on-premises and cloud systems (e.g., ERP, CRM, Databases, APIs). Build and maintain connectors, custom APIs, and triggers for scalable solutions. Optimize and troubleshoot existing Logic Apps workflows for performance and reliability. Work with Azure DevOps for CI/CD of Logic Apps and other integration components. Collaborate with business users, architects, and QA teams to understand requirements and deliver high-quality solutions. Ensure compliance with security, performance, and governance policies. Key Technical Skills required: Hands-on experience with Azure Logic Apps (Consumption and Standard models). Proficiency in Azure Integration Services: Service Bus, Event Grid, API Management. Experience with REST/SOAP APIs, JSON, and XML. Strong understanding of cloud-based integration patterns and middleware concepts. Familiarity with Azure Functions, Key Vault, Managed Identities, and Azure Monitor. Experience in troubleshooting using Application Insights, Log Analytics, and diagnostics.

**Job Summary** The CSV Specialist will lead and support Computer System Validation (CSV) activities, specifically for computerized systems used in the development and manufacture plantswithin a pharmaceutical environment. This role requires a deep understanding of CSV regulations, quality standards, and an ability to ensure compliance with both FDA 21 CFR Part 11, EU Annex 11, and other regulatory requirements. 1. **Validation Planning and Execution** - Lead and manage CSV projects for new and existing computerized systems, ensuring adherence to CSV lifecycle processes and compliance with regulatory standards. - Develop and maintain validation documentation, including validation plans, protocols, summary reports, and risk assessments. - Conduct system risk assessments, functional and technical assessments, and determine validation strategy. 2. **Regulatory Compliance* -Ensure compliance with FDA, EU, and global regulatory requirements, including 21 CFR Part 11 and EU Annex 11 . **Project Management** - Collaborate cross-functionally with IT, Quality, Manufacturing, and R&D teams to manage and execute validation projects, including system upgrades, migrations, and implementation of new computerized systems. - Develop and maintain project timelines and resource allocation, ensuring timely completion of validation activities. 4. **Documentation and SOP Development** - Author, review, and approve Standard Operating Procedures (SOPs), Work Instructions, and other CSV documentation. - Maintain and update documentation for validation activities, ensuring alignment with Good Documentation Practices (GDP). 5. **Training and Support** - Train and mentor team members on CSV processes, regulatory requirements, and best practices for maintaining validated systems. - Provide technical support during audits and inspections by regulatory authorities and internal quality audits. 6. **Continuous Improvement** - Identify and implement process improvements to enhance efficiency, compliance, and reliability of computerized systems. - Develop risk mitigation strategies and contribute to overall process excellence in CSV practices. ### **Qualifications** - **Education**: Bachelor’s degree in Computer Science, Engineering, Life Sciences, or a related field. Advanced degree preferred. - **Experience**: 10-15 years of relevant experience in CSV within the pharmaceutical and/or medical device industry. - **Technical Skills**: - Strong knowledge of FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and other regulatory standards. - Proficient in validation protocols, testing methodologies, and risk management principles. - Familiarity with IT infrastructure, software development lifecycle (SDLC), and Quality Management Systems (QMS). - **Soft Skills**: Excellent communication and interpersonal skills, with the ability to manage multiple stakeholders and work effectively in cross-functional teams. - **Certifications**: Preferred certifications include Certified Quality Engineer (CQE), Certified Software Quality Engineer (CSQE), or equivalent CSV-related certifications. ### **Other Requirements** - Ability to work in a highly regulated environment and under strict quality and regulatory guidelines. - Strong analytical and problem-solving skills, with a focus on compliance and risk-based validation. - Willingness to travel for audits, training, and support, as required.

Position Title: Group Leader- MS&T(Technical Documentation) Department Experience level Department-Location Evaluation of process suitability for New/Site transfer product and strategizing the implementation plan upon confirming its suitability, Evaluation of Analytical data and analytical development Lead a team & coordinate between FD, QA, RAD, ASD, QC, SCM, Finance & manufacturing for execution of Exhibit batches, validation batches of site transfer / tech transfer , provide documentation assistance , give technical inputs with in applicable regulatory guidelines with the objective of ensuring efficient and timely transfer of technology from development to commercialization Implementation of Pharmacopeial Updates and Source Change Document. Managing master data operations within the LIMS and SAP system. Developing, Optimizing, Validating, Verifying and Method transfer of analytical methods. Ensuring discipline in TrackWise by monitoring pending tasks and facilitating the closure of quality events. Ensuring adherence to regulations and maintaining the completeness of relevant logbooks or registers. Conducting on-the-job training sessions on departmental SOPs to maintain compliance.

Key Responsibilities of Role • Modelling and architecting robotic processes during the project development stage • Govern RPA processes from development to deployment. • Follow Quality Assurance (QA) & Compliance processes to ensure quality Automations • Updating and maintaining Developer Standards around RPA best practices Key Technical Skills Required : • Minimum 5 years of experience in a UI-path ecosystem. • Experience in developing workflow-based solutions or functionality • Should Lead team of 5+ members on Development, Operations & Support. • Must be able to multitask and willing to work on multiple projects at a given time • Strong written and verbal communication skills • Ability to work on deadlines and manage expectations • Strong analytical and problem-solving skills

Strides Arcolab Ltd. is looking for Company Secretary to join our dynamic team and embark on a rewarding career journey. To be a designated Company secretary for Group Companies at Vidyavihar (West) officeHandle documentation with high - level of confidentiality. To Manage the secretarial aspects of Board Meetings, AGMs, and other corporate activities including preparation, review and distribution of Notice, Agenda Items, Minutes of the meetings, Board Resolutions, and any other documents as applicable. To ensure and vet the contracts and other documents of the company keeping company interest ahead. Compliance and advisory work relating to Companies Act, ROC and other Secretarial Compliance. To maintain records of all documents required for Audit and establish the right auditable procedures. Prepare and present periodic compliance reports to senior managementTo assist Finance department as and when required

Position Title: Deputy Manager - Product Launch Department Experience level Department-Location Role - New Launch lead for EU market Job Description Budget Management Develop and manage launch budgets, track spending, and ensure projects are delivered on time and within budget Strategic Planning Enable on-time new product launches through effective planning and cross functional coordination Realign launch priorities in line with the evolving market dynamics Regulatory Compliance Ensure compliance with regulatory requirements and industry standards throughout the launch process. Cross-functional Collaboration Collaborate with RD, regulatory, marketing, and BD teams to align on product launches, positioning, timelines and other matters relevant for new launches Prompt escalation of delays and roadblocks for effective issue resolution Performance Monitoring Provide qualitative insights on launches and feedback on process improvement for better launch governance Timely reporting to Management on status and performance of new launches and budget achievement Pre-requisites Candidates having 5-8 years of experience in EU or SRA market is preferred Strong understanding of pharmaceutical regulations, industry trends, and market dynamics Proficiency in project management tools and software (preferable but not mandatory) Ability to work in a fast-paced environment and manage multiple priorities Excellent communication, negotiation, interpersonal and presentation skills

Position Title: Assistant Manager - Commercial operations Department Experience level Department-Location Role Commercial operations lead for EU market Job Description Execution of budgets Develop and manage budgets, to ensure that business and financial goals are achieved Supply planning Coordinate with planning and other cross functional teams to effectively plan product supplies Prompt escalation of delays and roadblocks for effective issue resolution of orders and supplies Customer management Managing all activities in relation to the customer (onboarding to sales to collection) oOnboarding and maintaining customer master oOrder book management oEnd to end sales monitoring oForecast alignment oRegular telecons with customers to keep them updates on the activities oQuery resolution oTarget achievement for every quarter the financial year for respective accounts oTrack and ensure on time EU testing and release with partner labs oOn time collections Regulatory Compliance Ensure compliance with regulatory requirements and industry standards throughout the supply and contract tenure. Collaboration Establish good working relationships with all customers as well as cross functional teams like manufacturing, SCM, finance, PDC, regulatory and logistics to drive business and financial objectives Performance Monitoring Measure and provide qualitative insights on forecast accuracy, DIFOT and suggest measures for improvement Timely reporting to Management on business, operational and financial performance Other matters Maintain SAP hygiene Pre-requisites Candidates having 5-7 years of commercial operations experience in EU or any SRA market is must Strong understanding of pharmaceutical business, regulations, industry trends and market dynamics Ability to work in a fast-paced environment and manage multiple priorities Excellent communication, negotiation, interpersonal and presentation skills Proficient use in Microsoft Excel, Power Point presentations and SAP.