Posted:2 months ago|
Platform:
Work from Office
Full Time
a. Having experience for EB /PV data compilation and report preparation and review.
b. Having experience for Executed document (BMR& BPR) review and compliance in coordination with validations requirement. c. Having exposure for hold time study data review and report compilation. d. Having exposure for sampling strategy of bulk and finished product in case of exhibit and commercial launch batches. e. Coordination with stability /micro/QC validation /production team for data collection and compliance as per validation requirement. f. Having exposure for QMS for validation recommendations closure and revision for routine commercials. g. Having exposure for document readiness and submission for product filing to regulatory department or client
Gracure Pharmaceuticals
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