Job Title : Junior Computer System Validation Engineer (Offshore) Reports To: Senior Manager or Manager Computer System Validation Employment Type: Internship, Followed by Full-time Workplace Type: Remote The Celito Team The Celito Team architects the buildout of simplified, integrated, and compliant technology stacks. With both consulting and products, our expertise can help our customers save time and money as they move from strategic Clinical & Quality management all the way to widespread and profitable commercialization. Job Overview The Junior Resource - Computer System Validation is responsible for execution of GxP Computer System Validation (CSV) activities in accordance with industry standards and regulatory guidance to ensure the systems are appropriately validated prior to release and remains in a compliant state throughout the lifecycle. Responsibilities and Duties Work collaboratively with project’s CSV lead and accomplish task with minimum guidance Authoring, review, and approval of CSV deliverables including but not limited to change controls, system risk assessments, validation plans, user and or functional requirements specification, configuration specifications, IQ/OQ/PQ protocols, traceability matrix, summary reports and applicable SOPs (System Administration and User/Operation) Perform execution to ensure the testing was performed appropriately and the test results are compiled in a timely manner Maintaining the validated state of client supported GxP systems including periodic review and release management Collaborate with offshore resources (in India) and onshore resources which means the candidate must be available until 11am PT US hours Qualifications Bachelor’s degree in life sciences or engineering or pharmacy Knowledge of performing validation of cloud-based Computer solutions and infrastructure qualification is a plus Work on multiple projects at the same time in a fast-paced environment, with limited supervision. Works with various clients, vendors, and team members to ensure project/program goals are met Strong written and oral communication skills, able to translate complex concepts across all levels of the organization Show more Show less
Job Title: Good Clinical Practice (GCP) QA Reports To: Associate Director/Director- GCP QA Employment Type: Full-time Workplace Type: Remote Timings: Flexible (Upto 2 am IST, few times a week) Travel : International Travel Required (15-45 days duration) THE CELITO TEAM The Celito Team architects the buildout of simplified, integrated, and compliant technology stacks. With both consulting and products, our expertise can help our customers save time and money as they move from strategic Clinical & Quality management all the way to widespread and profitable commercialization. JOB OVERVIEW We are seeking a highly skilled and experienced Senior Manager or Manager of Good Clinical Practice (GCP) Quality Assurance to join our team. This role is responsible for conducting GCP audits, providing consultations, and supporting clinical trial activities for our Research and Development (R&D) division. This role will involve strategic planning and implementation of GCP principles, supporting inspection readiness activities, and leading the Quality Management System (QMS) initiatives. The ideal candidate will possess significant decision-making authority on clinical quality matters and ensure the efficient operation of the QA department. KEY RESPONSIBLIITIES Conduct GCP Audits and Provide Consultations: • Perform on-site and virtual audits of clinical investigator sites, processes, documents, and vendors including CROs, central labs, IVRS, and data management. • Offer expert consultations and clinical trial support to R&D teams. Serve in an Advisory Role for R&D: • Advise Clinical Operations, Clinical Development, Statistics, Programming, Regulatory Affairs, Pharmacovigilance, and other R&D functions. • Review and provide feedback on clinical documents including protocols, consent forms, monitoring plans, and data management plans. Quality Assurance Activities: • Oversee quality assurance activities related to clinical, bioanalytical, diagnostic, safety, and pharmacokinetics analyses of clinical studies. • Ensure all activities comply with GCP guidelines and regulatory requirements. Lead GCP Inspection Readiness Activities: • Prepare for and lead GCP inspection readiness activities, including preparation, hosting, and responding to findings from regulatory inspections. • Develop and implement strategies to maintain continuous inspection readiness. Decision Making on Clinical Quality Matters: • Exercise significant decision-making authority on clinical quality matters, including addressing serious GCP breaches. • Provide guidance and recommendations for resolving quality issues. Support Quality Management System (QMS): • Author and review Clinical Quality Assurance (CQA) Standard Operating Procedures (SOPs). • Review and ensure alignment of functional area SOPs with GCP and regulatory standards. Collaboration and Communication: • Work closely with cross-functional teams to ensure alignment and compliance with GCP. • Provide training and mentorship to team members on GCP and quality assurance practices. Continuous Improvement: • Identify areas for improvement in clinical processes and practices. • Develop and implement corrective and preventive actions (CAPAs) to enhance quality and compliance. Leverage International Experience: • Utilize extensive experience working with US and European companies to navigate and comply with varying regulatory requirements. • Facilitate global clinical trials and ensure adherence to multinational GCP standards. QUALIFICATIONS • Master’s or bachelor’s degree in a relevant field (e.g., Life Sciences, Pharmacy, Medicine). An advanced degree is preferred. • 12- 15 years of experience in clinical research quality assurance or a related field. • Extensive knowledge of GCP guidelines and regulatory requirements. • Proven experience in conducting GCP audits and inspections. • Strong analytical and problem-solving skills. • Excellent communication and interpersonal skills. • Ability to work independently and as part of a multidisciplinary team. • Certification in GCP or related areas is a plus. • Extensive experience working with US and European companies. Show more Show less
Job Title : Good Manufacturing Practice(GMP) Quality Assurance Manager Timing : Overlap with PST hours - Upto 2 am IST Travel : International trips once every quarter expected Employment Type : Full-time Workplace Type : Remote THE CELITO TEAM The Celito Team architects the buildout of simplified, integrated, and compliant technology stacks. With both consulting and products, our expertise can help our customers save time and money as they move from strategic Clinical & Quality management all the way to widespread and profitable commercialization. JOB OVERVIEW We are seeking a highly skilled and experienced Manager/Sr. Manager of GMP Quality Assurance Operations to join our team. This leadership role is responsible for Quality oversight of CMOs manufacturing drug substance, drug product, and packaged product. This role will work closely with the CMC team to ensure compliance across the entire product lifecycle. The role ensures adherence to GMP and regulatory standards while driving continuous improvement. The ideal candidate will possess significant decision-making authority on quality matters and ensure the efficient operation of the QA department. KEY RESPONSIBLIITIES GMP QA Operations Responsibilities: Perform batch record review and compile documentation packages to support product disposition. Conduct technical reviews and approvals of Master Batch Records and executed batch records. Review and approve Deviations, CAPAs, Change Controls, and Audit reports. Perform technical reviews of Quality Control records, including Certificates of Release, Analytical Protocols, Reports, and Stability reports. Support and contribute to the Annual Product Quality Review. Author, review, and update QA Operations SOPs and other quality documents. Quality Oversight and Compliance Responsibilities: Ensure Quality and Compliance oversight of CMOs per quality agreements, including periodic site visits as needed. Oversee CMO/CSPs through remote collaboration, on-site visits, KPI monitoring, and adherence to quality agreements. Conduct vendor/CMO audits. Prepare, manage, and execute Quality Agreements. Provide Quality oversight and representation on external CDMO project teams; manage CDMO relationships. Coordinate and manage compliance activities in preparation for regulatory and internal inspections, and support interactions. External Audits and Regulatory Inspections: Lead preparations for external audits and regulatory inspections. Serve as the subject matter expert (SME) and host during audits and inspections. Develop and implement strategies to maintain continuous inspection readiness. Additional Responsibilities: Collaborate effectively with functional teams such as CMC, Supply Chain, and Regulatory. Escalate critical quality and compliance issues to management in a timely manner. Manage critical quality issues with Vendors/CMOs and provide prompt resolutions. Identify process gaps proactively and implement mitigation strategies. QUALIFICATIONS Bachelor’s degree in a relevant field (e.g., Life Sciences, Pharmacy, Chemistry, Engineering). Advanced degree preferred. 13+ years of experience in quality assurance role in the pharmaceutical industry required with at least 5+ years in Quality Operation roles in a current Good Manufacturing Practices (cGMP) environment Strong working knowledge of FDA regulations (21CFR, 210/211), ICH guidelines, and global regulations (EU Directives, and ROW) and expertise in the cGMP requirements pertaining to manufacturing and packaging operations (including serialization) in the United States and globally in support of global commercial production activities In-depth knowledge of cGMP and strong understanding of the entire product lifecycle. Proven experience in conducting GMP audits and inspections is preferred. Strong analytical and problem-solving skills. Excellent communication and interpersonal skills. Ability to work independently and as part of a multidisciplinary team. Certification in GMP or related areas is preferred. Experience working with US and European companies is required.
Job Title: IT Service Desk Technician Reports To: Senior Manager, IT Support Employment Type: Full-Time Timings : 11.30 am to 8.30 pm IST (Can extend upto 10.30 pm in case of meetings/issues) The Celito Team The Celito Team architects the buildout of simplified, integrated, and compliant technology stacks. With both consulting and products, our expertise can help our customers save time and money as they move from strategic Clinical & Quality management all the way to widespread and profitable commercialisation. Job Overview In this customer-facing role, the IT Service Desk Technician will play a key role in supporting our clients as the primary point for service calls and emails, tackling common and challenging issues. The role will also provide top-tier customer service and subject matter support in an on-site and/or remote environment. This position will provide troubleshooting and technical expertise to drive high first-call resolution. Responsibilities and Duties: Initial point of contact for all IT-related incidents and requests Work within the ticketing system to provide clients with timely and meaningful updates Troubleshoot IT-related issues remotely or in person and escalate any unsolved issues Image laptops (Windows OS and MacOS) and customise with company applications Support both Windows and Mac systems Document IT procedures, create runbooks and reports Continually improve IT support processes Onboard and offboard users on multiple platforms Train new hires on policies, procedures and technical skills Support with conference room AV Troubleshoot printers and Wired/Wireless networks Other duties, project work and responsibilities as assigned Requirements: 3+ years of experience with troubleshooting end-user issues and processing service requests as part of a service desk team Experience working in an IT Service Management platform or Help Desk ticketing system Senior or Team Lead experience in a Managed Service Provider (MSP) environment is a plus Experience with documentation and procedure design Technical certifications and/or related college coursework/degree (CompTIA, ACMT, HDI) are a plus Strong knowledge of Windows OS and Mac OS Strong knowledge of end-user hardware (PCs, office peripherals, Android/iOS devices) Experience in the following systems (Office 365, Okta, Zoom, SharePoint, CrashPlan, Druva InSync, CrowdStrike, Mimecast, DocuSign) Excellent customer service, communication and interpersonal skills Able to travel and work at customer sites as needed