Cipla - Head - Computer System Validation

This job exists to ensure that the GxP impacting computer systems used across all manufacturing units of Cipla and Cipla corporate function are in compliance with applicable requirements for Computer Systems Validation include Enforcement Policy 21: Part 11, Electronic Records; Electronic Signatures - Scope & Application; Annex 11, - Computerized Systems- of Eudralex Vol 4, Good Manufacturing Practice, Medicinal products for Human & Veterinary Use and Good Automated Manufacturing Practices (GAMP).

Accountability Cluster:

I. System Framework for Computer Systems Validation

II. Life Cycle Management of Computer Systems

III. Maintaining Validation Status of Computer Systems

IV. Handling of Deviations and Failures related to computer systems impacting Quality & Compliance

Educational qualifications:

- Graduate / Post graduate in Engineering, Pharmacy or Science. Preferably person with formal education in Computer Systems Validation

Relevant experience:

- Min 15-20 years of experience in Qualification, Validation and Computer Systems Validation with thorough & in depth understanding of Computer System Validations incl. Risk Assessment, System architecture, Traceability Matrix between URS, FS, TS and stages of Qualification / Validation; Life Cycle management of computer systems and Electronic Data Management .