| Quality Assurance CDMO Qualification Audit at Remote, Remote, USA |
| Email: [email protected] |
| From: Akash Sharma, Tek Inspirations [email protected] Reply to: [email protected] Need pharma experience Title Quality Assurance, CDMO Qualification Audit Location onsite(Michigan, north Carolina) Duration 6 months MOI: Skype Please attach dl and visa copy along with the resume Need local candidate Must have: Deep GXP and Quality Assurance Experience. CDMO Qualification Audit Experience, covering: Facility Qualification Review: Site Plan, Validation, Process Flow, Equipment, SOPs, Training. Quality System Review: Manual, Document Management, Change Control, Deviations/CAPA, Internal Audits, Vendor Management, Training. Stability Review: Chambers, Protocols, SOPs, Temperature/Humidity Logs, Study Processes. Material Management Review: Vendor Qualification, Raw Material Testing, Warehouse Mapping, Cold Chain, Controlled Substances. Laboratory Review: Equipment, Testing, Data Management, CofA, Data Integrity, IT Systems. IT Systems Review: Compliance, CSV, Data Security, Network, Employee Qualifications. Keywords: information technology |
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| Fri Oct 06 19:04:00 UTC 2023 |