Evaluate new packaging material and ensure the packaging fitness for use and handling of all packing material documentation which is part of quality system.
Ensure plant’s operations continue keeping pace with new KORE requirements, regulations, quality management methods and industry best practices.
Regular conduct the risk assessment for plant key processes to mitigate the risk of failure to deliver Quality product....
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Release incoming material, process, and product batches.
Participate in investigations arising out of non-compliance in incoming materials, QC testing, manufacturing processes, warehousing, and product.
Participate in change management, including change coordinator and/or QA oversight roles to ensure change plan is managed and complies with applicable policies....
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....
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....
Support external inspections (logistics and backroom support)
Support for other areas (Quality risk management, Quality Plan, QMR tasks and regulatory submission) in terms of management of open tasks, revision/routing of documents
At least 6 years QA experience in GMP manufacturing operations (API/Bio manufacturing) required, preferably in Quality Operations/Compliance...
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....