Executive/sr. Executive 21cfr

2 weeks ago

Jamnagar, India Adecco Full time

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

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