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Quality Assurance CDMO Qualification Audit at Remote, Remote, USA
Email: akash.s@tekinspirations.com
From:

Akash Sharma,

Tek Inspirations

akash.s@tekinspirations.com

Reply to:   akash.s@tekinspirations.com

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
akash.s@tekinspirations.com
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07:04 PM 06-Oct-23


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