14 Rims Jobs

You are a dynamic professional with expertise in high-value, A-class commodities such as Engines, Transmissions, Axles, and Hydraulic Components. You will be responsible for strategic sourcing, supplier management, cost optimization, planning & execution, SAP & Analytics, inventory optimization, cross-functional collaboration, and leadership. Your key responsibilities include: - Own procurement of Engines, Transmissions, Valves, and other critical parts - Track QCDD & OTIF, manage vendor performance - Lead VE/VA, localization, and total landed cost initiatives - Ensure on-time component availability aligned with production needs - Manage procurement data and generate actionable insights - Co...

As a Quality Management System (QMS) Specialist, your role will involve establishing, implementing, and continuously improving the company's QMS to support its clinical-stage biopharmaceutical development programs while ensuring compliance with regulatory requirements such as FDA, EMA, ICH, and GxP standards like GMP, GDP, GCP, GLP. Your responsibilities will include: - **QMS Development & Implementation**: - Developing, implementing, and maintaining a phase-appropriate QMS aligned with regulatory requirements. - Establishing, reviewing, and updating Quality System documentation to support GxP operations. - Serving as the system owner for the electronic QMS and ensuring effective document co...

As a Regulatory Data Quality Analyst at G&L Scientific, you will play a crucial role in supporting critical data remediation and migration activities as part of the RIMS implementation. Your focus will be on ensuring regulatory data integrity, compliance, and alignment with business needs. **Key Responsibilities:** - **Regulatory Data Remediation** - Review, cleanse, and standardize existing regulatory data - Identify and resolve inconsistencies, gaps, and duplications across regulatory systems and records - **Support Data Migration Activities** - Collaborate with IT and business teams to support extraction, cleansing, and upload processes into RIMS - Validate migrated data for accuracy, com...

Job Title: Associate Regulatory Affairs Specialist Experience: 5+ Years Location: Mumbai(Hybrid mode) Job Type: 12 months contract REQUIREMENTS: 5+ years supporting a regulatory or compliance organization. Experience in Regulatory Affairs or a related field, particularly within a compliance function. Hands-on experience with ETQ, RIMS, and document management systems. Familiarity with Indian regulatory guidelines and global compliance standards. Advanced proficiency in Microsoft Excel (VLOOKUP, Pivot Tables) and exposure to Power BI. Experience with SAP ERP systems and EQT or similar quality tracking tools. SUMMARY: We are seeking a detail-oriented and collaborative Regulatory Affairs Analys...

As a Senior Regulatory Associate (CMC) at Syneos Health, you will play a crucial role in ensuring compliance with regulatory guidelines and requirements. Your responsibilities will include: - Having a practical understanding of ICH guidelines, GMP requirements, and regional regulatory frameworks such as FDA and EMA. - Mandatory post-approval variation experience for the EU market and preferred pre-approval MAA dossier experience for ROW. - Strong expertise in preparing, compiling, reviewing, and submitting high-quality CMC dossiers for variations, renewals, annual reports, and RTQs. - Supporting change control assessment and impact assessments for global markets. - Executing day-to-day tasks...

As a Sr Regulatory Consultant specializing in Biologics/Biosimilars at Syneos Health, you will play a crucial role in authoring and reviewing CMC sections of regulatory submissions for various applications. Your responsibilities will include: - Authoring and reviewing CMC sections of regulatory submissions such as INDs, IMPDs, CTAs, BLAs, and MAAs, as well as briefing packages and health authority responses. - Ensuring completeness and compliance of CMC sections within IND and IMPD applications based on regulatory guidance (FDA, EMA, ICH). - Providing peer review and mentorship to junior writers or team members to maintain consistency and scientific accuracy across deliverables. - Staying up...

As a Techno Functional Consultant, you will play a pivotal role in working closely with the leadership team and key stakeholders in the RA/QA department. Your primary responsibility will be leading the implementation and support of Veera Vault as a technology platform to enable the transformation of Bio-Rad's QMS. You will be tasked with modernizing and harmonizing applications to reduce risks, enhancing proactive issue detection, standardizing reporting, and fostering a quality culture. Your expertise will ensure that Veera Vault technology aligns with the best business practices and processes. Additionally, you will collaborate with cross-functional teams to develop and deliver optimal tec...

As a Purchase Manager at Bull Machines Pvt Ltd, you will play a crucial role in the procurement of high-value, A-class commodities such as Engines, Transmissions, Axles, and Hydraulic Components. Your expertise in strategic sourcing, supplier management, cost optimization, and planning & execution will be instrumental in ensuring on-time component availability aligned with production needs. Your proficiency in SAP, Excel, data analytics, and AI will enable you to manage procurement data effectively and generate actionable insights. Additionally, your collaboration with cross-functional teams and leadership in mentoring team members will drive compliance with company standards. Key Responsibi...

Job Location - Chennai & Hyderabad Keywords Safety Systems, Regulatory submissions, labeling, publishing, RIMS (Veeva, etc.) Roles and Responsibilities Must Have Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Regulatory Sciences, or Computer Science. 4–8 years of experience in IT testing/validation, with 2–4 years in Regulatory Affairs systems Work with Regulatory Affairs, Publishing, Labeling, and IT teams to understand business processes and URS (User Requirement Specifications). Hands-on experience with Regulatory applications (e.g., Veeva Vault RIM, Lorenz docuBridge, Liquent InSight, Extedo eCTDmanager, or similar). Develop UAT strategy, test plans, test cases, and traceabili...

You will be responsible for handling regulatory affairs in XEVMPD (Extended Eudravigilance Medicinal Products Dictionary) and RIMS. The ideal candidate should have a minimum of 2-5 years of relevant experience in this field. Additionally, experience in veeva-vault for creating RO/SO events, XEVMPD submission, and knowledge of IDMP and QMS database will be beneficial for this role. The position is based in Mumbai.,

As a Senior Regulatory Consultant specializing in Biologics/Biosimilars at Syneos Health, you will play a crucial role in authoring and reviewing CMC sections of regulatory submissions for various applications such as INDs, IMPDs, CTAs, BLAs, and MAAs. Your responsibilities will include developing and ensuring the completeness of CMC sections within IND and IMPD applications while adhering to regulatory guidance from FDA, EMA, and ICH. Your expertise in analytical method development, validation, comparability, biosimilarity assessments, upstream and downstream process development will be essential. Furthermore, you will provide peer review and mentorship to junior writers or team members to ...

As the Manager-PRU Laboratory, your primary responsibility is to ensure compliance with safety rules and regulations, including the proper use of personal protective equipment (PPE), calibration, and training of manpower. You are expected to have a thorough understanding of PRU analysis for intermediate samples and final products, as well as knowledge of various product grades. Your duties also include monitoring the preparation of Standard Operating Procedures (SOPs), calibration, routine maintenance of instruments, and management of spares & chemicals inventory. Additionally, you will be responsible for safety protocols, external and internal audits, proficiency testing, in-house competenc...

As a Senior Regulatory Associate (CMC) at Syneos Health, you will play a crucial role in ensuring regulatory compliance by leveraging your practical understanding of ICH guidelines, GMP requirements, and regional regulatory frameworks such as FDA and EMA. Your responsibilities will include preparing, compiling, reviewing, and submitting high-quality CMC dossiers for variations, renewals, annual reports, and RTQs. In this dynamic role, you will be expected to support change control assessment and impact assessments for global markets, as well as execute day-to-day tasks according to client processes and SOPs to build high-quality global CMC dossiers. Additionally, you will be involved in trai...

Designation: Business Development Manager Managed IT Services Location Bangalore Experience - Minimum 5+ years relevant experience A Noventiq Value Point Systems Pvt Ltd Company, we're on a mission to transform businesses through cutting-edge solutions in Consulting, Integration, and Security. Are you a dynamic sales professional ready to accelerate our clients' Business Transformation Journey? For more details visit valuepointsystems.com No. of Positions- 1 No Identifying and making contact with new prospective clients for Managed Services ( FMS/ Hybrid Support/ Remote Support/ ITSM etc) Arranging meetings with prospective clients for Hybrid NOC Services. Highlighting the benefits/strengths...