Deputy Manager IT CSV

Experience

• Candidate with 3 – 5 years of experience in Pharma/Life science domain working knowledge in authoring on Computer System Validation Deliverables, Part 11/Annex 11, Data Integrity
• Work experience in Pharmaceutical Sector will be desirable
• Experience in Authoring all CSV deliverables e.g. URS, FRS, CS, IQ, OQ, PQ, RTM, VSR, Risk assessment, etc. as per V Model for IT projects
• Experience on validation of any of the enterprise level applications. e.g. Trackwise, Ensur/Documentum, LIMS, LMS, SAP/HANA, Chromatographic, Serialization, etc.
• Author, review and approval of SOPs, Guidelines/Policies as applicable.
• To have functional knowledge of Regulatory guidelines, Quality and Manufacturing processes.
• A team player with good communication skills (verbal & written)

Qualification

Graduate in Science/Pharmacy/Engineering

Post Graduation Science/MBA (Desirable)

Roles & 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 requirements. • 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 SPOCs for CSV activities and IT Compliance initiatives. • To guide and train IT & CSV teams (Corporate & Site) for CSV, Data Integrity and Regulatory Compliance activities. • Knowledge of IT systems and ITIL processes (e.g. Backup/Restoration, Infrastructure qualification, User access Management, etc.) • 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. Knowledge Required:- • 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) • Good Knowledge on Computer Software Assurance • 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.)