Senior Manager

1 week ago

Mumbai, Maharashtra, India Piramal Full time ₹ 6,00,000 - ₹ 18,00,000 per year


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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