Company Description Circulants is a rapidly growing IT solutions company based in Pleasanton, California. We specialize in assisting emerging Bio-Pharma companies to bring their products to market faster with our clinical and commercial data management platform on the cloud. Our global team works closely with clients to anticipate and accommodate evolving changes, ensuring desired outcomes. Our mission is to save clients time and money while providing cutting-edge solutions. Role Description This is a full-time on-site role located in Jaipur for a Salesforce Architect. The Salesforce Architect will be responsible for designing and developing Salesforce solutions, including Visualforce pages, Lightning Web Components, and overall Salesforce.com development. This role also involves Salesforce.com administration tasks and ensuring the Salesforce platform is optimized for performance and user requirements. Qualifications Experience with Salesforce.com Development, including Visualforce Pages and Lightning Web Components Proficient in Salesforce.com Administration Strong understanding of the Salesforce.com platform Excellent problem-solving and analytical skills Ability to work effectively in an on-site team environment Proven experience in IT solutions, preferably within the Bio-Pharma industry Bachelor’s degree in Computer Science, Information Technology, or a related field
Key Role 1. Develop, write, and maintain compliance and quality-related documents, including: 2. Standard Operating Procedures (SOPs) 3. Work Instructions (WIs) 4. Validation Protocols (IQ/OQ/PQ) 5. Risk Assessments 6. Quality Manuals 7. Audit Response Documentation 8. Collaborate with QA, Regulatory, IT, and Project teams to gather inputs and ensure document accuracy and clarity. 9. Translate complex technical and regulatory content into structured, user-friendly documentation. 10. Ensure all content complies with applicable FDA , EMA , and ICH guidelines and client-specific quality frameworks. 11. Assist in preparing documentation for client audits, internal assessments, and regulatory inspections. 12. Maintain version control, change history, and document archiving using tools like SharePoint , Veeva Vault , or Documentum . Contribute to the development of training materials and knowledge-sharing resources Role & responsibilities Technology Hands on Exp : AWS, Azure, GCP, SAS, BI, Databricks, sFTP, SaaS, PaaS, IaaS Domain: GDP, GxP, GAMP, CRO, 21 CFR Part 11, FDA, NDA, ALCOA+, QMS, SOP Preferred candidate profile We are striclty looking for System Validation side not For Medical Devices, Equipments or Instruments validation side Relevant Work Experience/Job Requirements: 1. Hands-on experience in Computer System Validation (CSV) including preparation of VMP, URS, FS, RTM, IQ/OQ/PQ, and validation reports . 2. Strong understanding of GxP, 21 CFR Part 11, EU Annex 11, and GAMP 5 guidelines with exposure to regulatory audits . 3. Experience with quality and compliance documentation including SOPs, change controls, deviations, and CAPA in a pharma environment. 4. Practical knowledge of EDMS/QMS systems, LIMS, MES, and electronic signature platforms . 5. Proven ability to collaborate with QA, IT, Manufacturing, and Regulatory teams for compliant system implementation and maintenance. Must have Skill sets required: 1. Computer System Validation (CSV) Expertise Hands-on in preparing and executing VMP, URS, FS, RTM, IQ/OQ/PQ, and validation reports. 2. Regulatory & Compliance Knowledge Strong understanding of GxP, 21 CFR Part 11, EU Annex 11, GAMP 5, and data integrity principles. 3. Quality Documentation & Audit Readiness Skilled in SOPs, change control, CAPA, deviations, and maintaining audit-ready records. 4. Technical & System Knowledge Familiar with EDMS, QMS, LIMS, MES, and electronic signature platforms in regulated environments. 5. Cross-functional Collaboration & Communication Ability to work closely with QA, IT, Manufacturing, and Regulatory Affairs teams. Technology Hands on Exp : AWS, Azure, GCP, SAS, BI, Databricks, sFTP, SaaS, PaaS, IaaS Domain: GDP, GxP, GAMP, CRO, 21 CFR Part 11, FDA, NDA, ALCOA+, QMS, SOP Other Skills: 1. Risk Assessment & Impact Analysis Ability to perform risk-based validation and assess system changes for regulatory impact. 2. Data Integrity & Audit Trail Review – Ensuring compliance with ALCOA+ principles and monitoring system audit trails.