Job
Description
To perform and author Computer System Validation activities of GxP Computerized as per defined processes at Corporate IT and across Piramal Pharma sites. KEY STAKEHOLDERS: INTERNAL Business - Site / Corporate functions IT Team (e. g. SAP/ Infra / Quality IT / Allied / SAP Basis) KEY STAKEHOLDERS: EXTERNAL IT Vendors IT Contractors/Consultants REPORTING STRUCTURE: Will report to - Chief 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 SKILLS AND COMPETENCIES 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) 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 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. 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. ) (Must) QUALIFICATION: Graduate in Science/Pharmacy/Engineering Post Graduation - Science/MBA (Desirable)
