Senior Manager IT Computer Validation System

3 days ago

Mumbai, Maharashtra, India Piramal Critical Care Full time ₹ 12,00,000 - ₹ 36,00,000 per year

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/ Direct Reports Y/N)

AGM IT - CSV

ESSENTIAL QUALIFICATION:

  • Graduate in Science/Pharmacy/Engineering
  • Post Graduation MPharm/Science/MBA (Desirable)

RELEVANT EXPERIENCE:

  • 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

KEY ROLE AND 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 SPOCs 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.

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