Senior Manager
6 days ago
Business: Piramal Critical Care
Department: Information Technology
Location: Kurla
Travel: Low
Job Overview
To perform and document Computer System Validation of GxP Systems as per defined processes at Central Partner Functions and across Piramal Critical Care sites.
Key Stakeholders: Internal
- Business – Site / Central Partner functions
- IT Team (e.g. SAP / Infra / Quality IT / Allied / SAP etc)
Key Stakeholders: External
IT Vendors, IT Contractors/Consultants, Piramal CSV Partner
Reporting Structure
Reports to: AGM IT - CSV
Education Qualification & Experience
- Graduate in Science/Pharmacy/Engineering
- Post Graduation – MPharm/Science/MBA (Desirable)
- Candidate with 10-14 years of experience in Pharma/Life science domain working on CSV, Part 11/Annex 11, Data Integrity
- Work experience in Pharma or IT Sector will be desirable
Roles & Responsibilities
- Must have thorough understanding, practical approaches for Computer system validation (CSV) & Computer Software Assurance 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 end to end CSV deliverables for IT projects e.g. URS, FRS, CS, IQ, OQ, PQ, RTM, VSR, Risk assessment, etc.
- 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 support Quality Automations Initiatives across the Central Partner functions/PCC/PPL sites.
- To liaise with Site IT , Business SPOC's for CSV activities and IT Compliance initiatives.
- To guide and train IT & CSV teams (Central Partner Functions & Site) for CSV, and CSV Regulatory Compliance activities.
- To work along with Business, IT, QeC & Project Manager to ensure project timelines are met.
- Experience on validation of any of the enterprise level applications. e.g. Track wise, Ensur/Documentum, Paperless Validation Tools, LIMS, LMS, SAP, RIMS Applications, Artwork management Systems, Serialization, Veeva etc.
- Author, review and approval of SOPs, Guidelines/Policies as applicable.
Competencies
- Good knowledge of 21 CFR Part 11 / Annexure 11 (Must)
- Good knowledge of CSV, CSA,GAMP 5 Guidelines (Must)
- Good knowledge of Data Integrity requirements for Pharma (Must)
- Experience in working with various geographical Location Stakeholders such as US, European, APAC. (Must)
- Experience of working with Global Pharma Cross functional Sites – QC, QA, Manufacturing, IT, SAP 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 CSV 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.)
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