Manager-CSV-IT

Be the First to Apply

Division

Piramal Pharma Solutions

Piramal Pharma Solutions is a contract development and manufacturing  organization (CDMO), offering end-to-end development and manufacturing  solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.  

This enables us to offer a comprehensive range of services including Drug Discovery  Solutions, Process & Pharmaceutical Development services, Clinical Trial  Supplies, Commercial supply of APIs and Finished dosage forms. We also offer  specialized services like development and manufacture of Highly Potent APIs  and Antibody Drug Conjugation.  

Our capability as an integrated service provider  & experience with various technologies enables us to serve Innovator and  Generic companies worldwide.  

For more details, please visit : www.piramalpharmasolutions.com

Job Title

Manager-CSV-IT

Job Description

1. End to CSV for Labware LIMS Modules.
2. Authoring of all CSV Deliverables such as VP, IRA,IQ,OQ,PQ, VSR etc
3. Well versed with 21 CFR Part 11, Annex-11 as per Regulatory Compliance requirements

•To have thorough understanding, practical approaches for Computer system validation (CSV) of enterprise level applications.

•Accountable for authoring CSV Deliverables for Enterprise  GxP Applications especially Labware LIMS, SAP S/4 HANA, DMS, LIMS etc

•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 QMS documents e.g. Change control/Impact Assessments, Deviation/Incidents-Discrepancy/User access forms.

•To perform Root cause analysis and define CAPA based on QMS documents review.

•To support the initiatives undertaken Under Quality Automations and Project Catalyst.

•To liaise with Site IT, QeC, Business 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.

Key Competencies -

•Good knowledge of Labware LIMS Modules such as Lot, Sample, Instrument, Inventory, Stability Management.

Good Knwoledge in 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

•Functional knowledge of Regulatory guidelines, Quality Control and Manufacturing processes. (Plus)