Building Quality In Upstream
Quality Assurance
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Initiation, approval and distribution of procedures (SOP’s)
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Coordination and approval of validations & qualifications
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Handling of Incidents, Deviations, Change controls
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Training
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CAPA
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Storage and monitoring Finished Product Retention / Control samples.
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Handling and Investigation of market Complaints.
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Product Recall.
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Batch Release of Finished Goods (SAP)
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Self Inspection.
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Vendor Qualification
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Product Quality Review
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QC Lab is independent from the Production Area.
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Responsible for Sampling, testing and releasing of Raw materials and packing materials.
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Reporting and Investigation of Out of specification & Out of Trend (if any).
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Primary, working and Reference standards procurement, standardisation and storage.
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Storage and monitoring Raw Material Retention / Control samples.
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Microbiological sampling, testing and releasing.
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Sampling, Testing and Releasing of RM, PM, In-process, Finished product & Stability samples.
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PPE’s are in place for personnel safety.