Senior Manager

4 weeks ago

Mumbai, Maharashtra, India Piramal Enterprises Full time
Job Description

Job Description :

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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