A Premier CDMO. FDA Registration #1210580.
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Quality Systems Compliance Group

Approve documents within EDMS, including:

•INV, DEV, VAR, OOS, OOT, CC, CAPA

•Manufacturing Validation Protocols / Executed Val’s / Reports

•Packaging Validations Protocols / Executed Val’s / Reports

•Analytical Method Validation/Verification Protocols / Executed Val’s or Ver’s / Reports

•Stability Protocols / Reports

•IQ/OQ/PQ Protocols

•IQ/OQ/PQ Protocols / Executed IQ/OQ/PQ

•Executed PM/Cal

•SOP’s

•Validation and Commercial MBR’s

•Validation and Commercial PWO’s

Approve laboratory data in LIMS system:

•Data integrity

•Methods

•Specifications

•Results

Additional responsibilities include:

•Hosting Regulatory and Client Audits

•Complaint Handling Unit

•Material Review Board

•Annual product reviews