Posted:1 month ago|
Platform:
Work from Office
Full Time
1.0 Working / Real time experience on Digital platforms like DMS, TMS, ERP, LIMS, QMS and different application software used in production and QC.
2.0 Knowledge on 21 CFR PART 11, GAMP guidelines.
3.0 Provide expertise and guidance to the project/cross function team on computerized system validation activities to meet GxP regulatory needs with focus on Data Integrity.
4.0 To ensure computerized systems validation, and compliance throughout the life cycle of the Equipment/system to comply with the site procedures and Regulatory requirements.
5.0 Preparation of Computerized Systems Validation Master Plan and Gap assessment (if required) as and when needed.
6.0 To Identify and mitigate risks related to computerized systems at the site level. Prepare/support risk assessment documents and ensure execution of validation activities based on assessed risk.
7.0 Knowledge on computerized system inventory and GxP risk classification/ Impact Assessment.
8.0 Review and preparation of URS, FS, IQ, and OQ documents related to GxP computerized system, IS infrastructure and participate in qualification/validation or compliance verification of computerized systems.
9.0 Knowledge on Audit trail review.
10.0 Prepare/ review the computerized systems SOPs and ensure the site, GxP regulatory requirements.
Curateq Biologics
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