3 Cds Systems Jobs

You will be responsible for providing SDMS Support for Empower system with 4 - 10 years of experience in Pan India location with an immediate notice period. Your role will involve the following responsibilities: - Demonstrating strong technical knowledge on Empower and other CDS Systems. - Maintenance and support of the current CDS system. - Providing end user issue support, troubleshooting, and resolution. - Administration of CDS system, including server maintenance. - Performing backup, archival, restore, and periodic review of the system. - Supporting deployment and installation of CDS applications. - Having complete knowledge of user management of lab applications. - Coordinating with multiple instrument vendors during application instrument setup and instrument qualification. - Providing proper training and support to Site SMEs in Empower operations and implementations. - Working experience in Pharmaceuticals, Chemical Manufacturing, or any regulated environment. - Possessing excellent verbal and written communication skills. - Validating all laboratory and instrument software, including maintenance of the Master Validation Plan, functional requirements, risk assessment, and execution of validation protocols. - Ensuring data integrity and compliance to 21CFR Part 11 and GxP standards. - Drafting and finalizing SOPs and compliance documents. If you have the required experience and skills in the mentioned areas, we encourage you to apply for this position and be a part of our dynamic team.,

The Laboratory Information Management System (LIMS) Analyst role requires 4 to 6 years of relevant experience. As a LIMS Analyst, you must have independently managed at least one full Labware LIMS implementation or upgrade project. It is essential to be knowledgeable about GxPs, Computer System Validation processes, and other regulatory requirements in a laboratory setting. Proficiency in writing complex SQL queries in Oracle is a must. Additionally, the ideal candidate should possess over 4 years of hands-on experience in configuring, customizing, and deploying Labware LIMS, preferably in an updated version. Exposure to Labware ELN/MEX (method execution system) is advantageous. Proficiency in building deployment packages is required, along with excellent skills in LIMS development and configuration. Furthermore, troubleshooting and debugging LIMS applications, customer-facing abilities, strong analytical skills, effective communication, and articulation skills are essential for this role. Hands-on experience in implementing Instrument interfaces and CDS systems is preferred. Other responsibilities include Labware configuration, development of subroutines/calculations, mentoring, and team-building. The successful candidate will collaborate across multiple teams to address challenges and drive progress in project deliveries. The hiring process for this role includes screening (HR round), Technical Round 1, Technical Round 2, and Final HR Round. If you meet the required skills and experience for this Laboratory Information Management System (LIMS) Analyst position and are looking for a challenging opportunity in PUNE, we encourage you to apply.,

Roles & Responsibilities: Oversee the software, hardware, and firmware development lifecycle for CDS application, ensuring standard methodologies in development, testing, and deployment across the Global Process Development Organization Work within the framework of SAFe product team, participating in requirements gathering, design discussions, development, implementation, testing, and software validation. Ensure the quality, reliability, and scalability of the CDS applications, following the standard methodologies of software engineering, testing, and documentation. Research and evaluate new technologies and frameworks that can enhance the capabilities and performance of the software solutions. Remain accountable for ensuring overall organizational compliance with quality and GxP in technology services Monitor emerging technologies and trends to find opportunities for platform growth and expansion Apply machine learning and Gen AI techniques to accelerate operational business process flows associated with CDS applications and leverage CDS data to generate insights and provide recommendations for process improvement. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Doctorate degree OR Master s degree and 4 to 6 years of Life Science / Biotechnology / Pharmacology / Information Systems experience OR Bachelor s degree and 6 to 8 years of Life Science / Biotechnology / Pharmacology / Information Systems experience OR Diploma and 10 to 12 years of Life Science / Biotechnology / Pharmacology / Information Systems experience Preferred Qualifications: Functional Skills: Must-Have Skills: Demonstrated experience of owning business applications in a Life Sciences, Pharmaceutical, Biotech company or equivalent industry or knowledge of the pharmaceutical industry GxP system qualification and validation processes for computer related systems Strong knowledge of COTS (Commercial-off-the-shelf) Validations on HPLCs, UPLCs, CEs, GCs, and other standalone systems Proven leadership skills with the ability to lead projects and work closely with a team of hard-working technology professionals Build a culture of innovation and continuous improvement within the team to deliver powerful solutions and platform improvements Solid skills in collaborating and communicating with multi-functional teams, business collaborators, and executives to ensure alignment of platform initiatives with business outcomes, handling expectations, and ensuring successful delivery of projects. Experience with Advancing Capabilities and Delivering Innovative Technology Solutions in a Pharma/Biotech environment Degree in Computer Science, Information Systems, Engineering, or Life Sciences Good-to-Have Skills: At least 5 - 8 years of domain knowledge in health and/or life sciences combined with Information Technology Extensive experience in software development lifecycles Experience using and adoption of Scaled Agile Framework (SAFe) Understanding of ITIL processes and implementation Experience handling vendor relationships and working with external partners or consultants to ensure optimal performance, support, and development of digital products Soft Skills: Excellent leadership and team management skills. Strong transformation and change management experience. Ability to work effectively with global, virtual teams. Excellent analytical and troubleshooting skills. Ability to manage multiple priorities successfully. Strong presentation and public speaking skills. Strong verbal and written communication skills. High degree of initiative and self-motivation.