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| Job Location | Mumbai City |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | Manufacturing |
| Functional Area | Operations Management / Process Analysis |
| EmploymentType | Full-time |
*Key Roles and Responsibilities:To have thorough understanding, practical approaches for Computer system validation (CSV) of enterprise level applications. Accountable to ensure compliance of CSV documentation during various phases (project, operational & retirement) of software lifecycle (SLC).Well aware with GAMP5, CFR Part 11/EU Annex 11 and Data integrity requirementsTo create CSV deliverables for IT projects e.g. URS, FRS, CS, IQ, OQ, PQ, RTM, VSR, Risk assessment, etc.To create infrastructure ((Network, Servers, Cloud, Database) qualification documentation.To create QMS documents e.g. Change control/Deviation/Incidents-Discrepancy/User access forms To perform Root cause analysis and define CAPA based on QMS documents review. To perform periodic and audit trail review of computerized systems as per defined frequency.To support the initiatives undertaken by Quality eCompliance and CSV team across the Corporate/PEL sites Perform IT Supplier assessment and ensure compliance of audit observations.To liaise with Site ITC SPOC s for CSV activities and IT Compliance initiatives. To guide and train IT & CSV teams (Corporate & Site) for CSV, Data Integrity and Regulatory Compliance activities.Ability to represent during regulatory audits and can able to perform Corporate & DI Audits of sites.To work along with CSV & Project Manager to ensure project timelines are met.Experience on validation of any of the enterprise level applications. e.g. Trackwise, Ensur/Documentum, LIMS, LMS, SAP, Chromatographic, Serialization, etc.Author, review and approval of SOPs, Guidelines/Policies as applicable.Skills and Competencies:Good knowledge of 21 CFR Part 11 / Annexure 11 (Must)Good knowledge of CSV, GAMP 5 (Must)Good knowledge of Data Integrity requirements for Pharma (Must)Experience of working at Pharma Site QC, QA, IT, CSV etc. (Plus)Experience of validation on automation/digitization projects (Plus)Good Verbal and Written communication skills (Must)Aware of industry best practices and knowledge about Pharma 4.0 (Plus)Functional knowledge of Regulatory guidelines, Quality Control and Manufacturing processes. (Plus)Knowledge of IT systems and ITIL processes (e.g. Backup/Restoration, Infrastructure qualification, User access Management, etc.) (Must), *Graduate in Science / Pharmacy / EngineeringPost Graduation Science / MBA (Plus)
Keyskills :
it projectsit compliance21 cfrroot cause analysisaudit trailcontinuous improvement facilitationdata integritycomputer system validationroot causequality controlrisk assessmentstatements of work sow