Lead review and approval of batch records, investigations, deviations, change controls, CAPAs, quality risk assessments, protocols, reports, and GMP documentation.
Make independent quality decisions on product quality, compliance, batch disposition, material release, and manufacturing events to support uninterrupted operations.
Provide timely quality support and guidance to Manufacturing during shift operations, including deviation assessment, event management, and resolution of quality-related issues.
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Liaise with internal stakeholders (Manufacturing, QC, Engineering, Validation, Warehouse, Procurement, and Quality functions) to support supplier qualification decisions.
Review supplier documentation including business licenses, GMP certificates, ISO certifications, audit reports, quality manuals, and supporting compliance records.
Leverage supplier qualification documentation and audit information from affiliate or global sites where applicable.
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Provide quality oversight for Validation, Engineering, Utilities, HVAC, Process Gases, IT/Computerized Systems (CSV), Warehouse, and Quality Control operations.
Ensure SOPs, Quality Risk Assessment, reports, specification and quality records comply compliance with FDA cGMP, EU GMP, PIC/S GMP, ICH Guidelines, Data Integrity requirements, and company quality standards..
Provide independent quality decisions to ensure product quality, patient safety, data integrity, and regulatory compliance.
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Manage material / supplier qualification in compliance with cGMP requirement and internal procedures.
Manage QA review and release of incoming materials and sterile buffers in compliance with cGMP requirement and internal procedures.
QA review and approve LSOPs, checklists, incoming material documentations, deviations, CAPAs, change controls, and quality tag outs, in accordance with quality and compliance expectations.
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Keeps up-to-date on regulations/ development of biopharmaceutical QC method/ technology to ensure the project maximizes the use of digitalization, automation and robotics.
Works closely with global/local QC stakeholders to develop and endorse the following: --Analytical transfer plan and Validation master plan, cost management (eg. facility, analytical equipment) and training plan
Collaborates closely with global QC departments on test method innovation/ evaluation to support the project team in facility design / modification specifically for QC operations.
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Keeps up-to-date on regulations/ development of biopharmaceutical QC method/ technology to ensure the project maximizes the use of digitalization, automation and robotics.
Works closely with global/local QC stakeholders to develop and endorse the following: -Analytical transfer plan and Validation master plan, cost management (eg. facility, analytical equipment) and training plan
Collaborates closely with global QC departments on test method innovation/ evaluation to support the project team in facility design / modification specifically for QC operations.
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Manage material / supplier qualification in compliance with cGMP requirement and internal procedures.
Manage QA review and release of incoming materials and sterile buffers in compliance with cGMP requirement and internal procedures.
QA review and approve LSOPs, checklists, incoming material documentations, deviations, CAPAs, change controls, and quality tag outs, in accordance with quality and compliance expectations.
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