Share in preparing performance qualification protocols and validation reports for different validation activities such as:A) Process validation.B) Media fill.C) Qualification of visual examination.

IPC testing during all steps of product manufacturing in accordance withgovernance SOPs.• Ensure proper sampling of intermediate, bulk and finished productbatches for routine testing, validation practices and cleaning samples.• Follow up application of quality assurance measures in production areasand check compliance of IPC testing.• Ensure implementation of procedures of batch manufacturing andpackaging documents, specifications & SOPs.• Ensure application of quality assurance measures during validationbatches and planned changes.• Monitor calibration of production equipment and IPC testing instruments.• Review batch related documentation for completeness, correctness, andcompliance to approved standards.• Report any observed incidents during routine production and follow upits correction and corrective action.• Ensure that GMP Standards are followed properly in the Warehouse,Dispensing and manufacturing areas and during the manufacturing andpackaging processes.• Participate deviations, complaints, OOSs & OOTs in coordination witharea owners and ensure implementation of CAPA and closure withinrequired timeline.• Ensure identification and rejection of non-conforming materials/productsaccording to GMP standards.

1-Carry out in-process tests to ensure product compliance with established specs and provide related reports accordingly.2-Monitor the environmental conditions (Temp. %RH, ΔP)compliance with GMP requirements.3-Monitoring GMP & system implementation on daily basis and providing related reports accordingly.4-Withdrawing IPC & finished samples for QC department as per established sampling plan.5-Monitor the calibration and verification of monitoring and measuring devices.6-Supervise the dispensing process of raw and packaging materials.7-Verify the batch records and logbooks completeness.8-Aid in all aspects of QA activities related to internal audits as well as external audits and reviews.

1-High Performance Liquid Chromatography (HPLC)2-Total Organic Carbon (TOC)3-PH 4-Conductivity