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