Go Back

Project Details

IT CSV Consultant

Indian Bio Pharmaceutical Company


Posted on:  29/11/2022

Cinque Terre

Starts on:  29/12/2022


Information Technology


Quality Assurance & Testing, Technology Operations and Support,



Company Details

Indian-based global biopharmaceutical company changing patients’ lives in over 120 countries by finding new and affordable ways to treat diabetes, cancer, and autoimmune diseases.

Assignment Details

Our Client, an Indian Bio-Pharmaceutical company is looking to engage with a IT CSV SME.

Key Responsibilities-

1. CSV Consultant who will serve as an SME and assist the IT System Owners in
managing the CSV deliverables.
2. Author Validation Plan and Validation Summary reports.
3. Provide guidance in drafting ERES Assessments, Risk Assessments, Plans and Summary.
reports, QMS Events, Deviations, CAPA, Change Controls, Periodic Review Reports
4. Support multiple projects in parallel.
5. Assist the ITQA leads and IT System Owners during inspections and remediation efforts.

Skills Required

1. 6-8 years of experience in IT.
2. Experience in SDLC processes, Quality Control, Quality Assurance, Computer Systems Validation and GxP Compliance.
3. Deep expertise in 21 CFR Part 11, EU Annex 11, GAMP5 guidance.
4. Excellent document writing and reviewing skills specifically with experience in
Pharmaceutical CSV documentation.
5. Experience in qualifying IT CSV tools such as HP ALM, Validator, Valgenesis.
6. Experience in internal/external audits and inspections (Conducting as well as responding to).
7. Experience working with technical teams, OEM product teams and other project stakeholders to gather inputs on CSV deliverables (ERES Assessments, Risk Assessments, Plans and Summary reports, QMS Events, Deviations, CAPA, Change Controls, Periodic Review Reports).
8. Ability to deal with uncertainties and navigating through ambiguities

Assignment Duration

6 month(s)

Capacity Required

Full Time

No. of Positions


Nature of Work


Profile Requirements

Experience: 6+ years

Qualification : Post Graduate or Higher

fleXpertise required

Quality ControlQuality AssuranceIT CSV


- | Terms of use | Privacy policy | Contact us
©2018 Flexing It® Services Private Limited. All Rights Reserved.

This website uses cookies to ensure you get the best experience on our website. By continuing to use this site, you agree to our cookie policy. Accept