Regarding: 3 months GxP CSV (Computer System Validation) Contract Work opportunity
₹37500-75000 INR
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게시됨 약 1년 전
₹37500-75000 INR
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Hi,
Wanted to quickly connect to discuss about 3 months CSV Contract Work opportunity that requires relevant experience of 5+ years for Contract work of 3 months
Location: Hyderabad, Work Onsite (Client Premises)
MUST have: Performing following remediation / validation activities of Engineering / Lab equipment(s) which includes:
a. Work with System owners / POCs to quickly understand the current intended use / needs of each lab equipment and their compliance gaps and accordingly complete remediation activities (listed below):
b. Drafting GxP Assessment, validation Plan, 21 CFR Part 11, Vendor Assessment, Disaster Recovery Plan & Validation Summary Report.
c. Performing the Risk Assessment, documenting & tracking Risk mitigations / action plan
d. Conduct Periodic review
e. Creating and review of technical documentation: URS, FRS, Configuration / Design specification
f. Creating and review of Test scripts (IQ, OQ, PQ) and End 2 End Traceability Matrix (from URS to PQ) and support executing the Test protocol and handle deviations (CAPA).