5 Rims Jobs

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 ensure consistency and scientific accuracy across deliverables. Experience with post-approval changes, tech transfers, and product lifecycle management will also be valuable in this role. In addition to primary skills, deep understanding of CMC regulatory requirements for biologics/biosimilars and experience with biosimilars, monoclonal antibodies, recombinant proteins, or other biologics are secondary skills required for this position. Ideally, you should possess a minimum of 8 years of experience in CMC-Biologics along with a Master's degree in pharmaceutical sciences or other life sciences. Your ability to work independently, manage multiple priorities in a fast-paced consulting environment, and attention to detail are crucial for success in this role. Experience with RIMS/Veeva Vault for submission management and regulatory compliance is preferred. At Syneos Health, we are dedicated to developing our employees through career progression, supportive line management, training programs, and a total rewards program. Our Total Self culture fosters an environment where authenticity is encouraged, and diversity of thoughts and perspectives are valued. Join us in our mission to accelerate the delivery of therapies and change lives. Learn more about Syneos Health and the impactful work we do across 110 countries with 29,000 employees.,

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 competency monitoring, and ensuring adherence to international standards such as ASTM, IP, UOP, ISO, BIS, APHA, etc. Your role involves highlighting any deviations from product specifications and assisting the Shift In-charge as needed, including taking on additional responsibilities when required. You will be accountable for new method/technology development, innovation/improvement in the lab, and ensuring the smooth functioning of the laboratory operations. In terms of team management, you will oversee the testing of intermediate and finished product samples, ensuring adherence to test methods, reliability of results, and timely validation in the Laboratory Information Management System (LIMS). You will also be responsible for instrument calibration, SOP preparation, documentation, and handling troubleshooting of instruments. Planning and budgeting, procurement of spares/consumables, and monitoring inventory will be part of your routine tasks. Your role extends to creating and implementing management frameworks to achieve targeted outcomes efficiently while complying with process design standards and statutory regulations. You will have the authority to make corrections in the analytical process, ensure timely report releases, and address any abnormalities or product failures promptly. Furthermore, your responsibilities include coordinating internally and externally for sample analysis, addressing customer complaints, providing feedback, and supporting customer developmental activities. You will also be accountable for implementing and improving Environmental Management Systems (EMS) and Occupational Health and Safety Management Systems (OHSMS) within the laboratory. Key challenges in your role include managing abnormal samples and results, ensuring instrument performance and calibration, maintaining inventory, troubleshooting instruments, and complying with NABL accreditation processes. You will be expected to make key decisions related to measurements, convey decisions to stakeholders, and recommend improvements in analytical practices and operations. Interdepartmental interactions, coordination with subordinates, area managers, external vendors, and customers will be crucial for successful laboratory operations. Your educational qualifications should include a B.Sc. or M.Sc. in Chemistry with at least 15 years of experience in PRU/Petroleum Refinery/Petrochemical laboratory settings. Additionally, you should possess functional skills in coordination, testing standards, LIMS, RIMS, IQCM, instrument handling, calibration, and troubleshooting, along with a sound understanding of product quality parameters and safety standards. Your behavioral skills should include team-building, result orientation, customer focus, operational excellence, and continuous learning and training abilities. In summary, as the Manager-PRU Laboratory, you play a vital role in ensuring the efficient and compliant operations of the laboratory, managing a team, maintaining quality standards, and driving continuous improvement in processes and procedures.,

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 training and mentoring team members as needed based on project requirements. Your role will also entail liaising with cross-functional teams including Quality, Manufacturing, Analytical, etc., to gather necessary technical data and ensure regulatory consistency for global submissions. You should possess excellent written and verbal communication skills and be open to working in Cross-Cultural/Virtual teams, attending client meetings as required with relevant inputs. To qualify for this position, you should have a minimum of 4 years of experience in preparing, compiling, reviewing, and submitting high-quality CMC dossiers for variations, preferably with a Masters degree in pharmaceutical sciences or other life sciences. The ability to work independently, manage multiple priorities in a fast-paced consulting environment, and experience with RIMS/Veeva Vault for submission management are essential qualifications for this role. Syneos Health is committed to developing its employees through career development and progression, supportive line management, technical and therapeutic area training, peer recognition, and a total rewards program. Join us in our mission to accelerate the delivery of therapies and make a difference in the lives of patients worldwide. Find out more about Syneos Health and our impactful work at http://www.syneoshealth.com.,

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 of the Valuepoint IT Managed Services Experience in selling IT services ( AMC/ FMS/ NOC/ RIMS/ SOC) Coordinate with Presales and technical team for WebEx/ POC Meeting clients at their offices, identifying their requirements and then proposing solutions Experience of ITSM tools ( Service Desk, End Point Management, Data Centre Management will be added advantage) Excellent communication written and verbal skill is must Well versed using social media networks LinkedIn and other professional networks interested candidate can forward cv to jyoti.patil@valuepointsystems.com