Job Description

About Company:
Our client is a vertically integrated global pharmaceutical company, specializing in formulation development, manufacturing, and marketing. Dedicated to addressing unmet medical and societal needs through a comprehensive pharmaceutical value chain across the world
An Ideal Candidate:
An ideal Candidate will be responsible to work along with IT-QA Team and Business Project Manager in defining technical controls & compliance requirements to the computerized systems to prevent Data.
Key Competencies:
1. To ensure technical controls are effectively implemented across Manufacturing & Quality IT applications.
2. To ensure 'Audit Trail and Electronic data' review of IT systems through 'Review by exception' rule to enhance overall compliance on generated & reported data.
3. Preparation and review of the Validation deliverable (i.e. VP, URS, FS, FRA, IQ, OQ, RTM, VSR).
4. To perform Periodic review of computerized system.
5. To impart training in Computerized System Compliance with respect to 21 CFR Part 11.
6. Review and drive Change control, CAPA, Deviation, Investigations activities.
7. To participate in self-inspections to ensure GMP and data integrity compliance and identify the improvement areas for continual compliance.

Skills Required