• SOPs Preparation and implementation.• Bioburden Testing of Different Raw materials, Products (All Disposable Medical Devices, IV Infusion Solutions, Primary Pharmaceutical Packing and food productpackaging)• Environmental Monitoring of Sterile Areas/clean rooms based on classification.• Microbiological Testing of all sterile product (IV Solutions, Medical Devices etc),Non-Sterile Products (Pharmaceuticals and NON-Pharmaceuticals) & Primarypackaging of food products.• Clean Room Validation based on ISO 14644.• Microbiological test (i.e:- BET Testing, Growth promotion test, gram staining,Microbial Identification, Total aerobic Microbial count, total Yeast and Mold Count etc)• Risk Management analysis,PFMEA,Control Plan. • Deviation, Root Cause analysis (RCA) Tools & corrective and Preventive action (CAPA) and also Certified for RCA and CAPA.• Technical Files Preparation for Medical Devices as per MDD/MDR and DRAP.• Have a good command on GMP, GHP GLP, & Good documentation Practices.•maintain complete Quality Control and Quality assurance record.• Certified Internal Auditor (ISO 9001, ISO 14001, ISO 13485 & IMS) and GMP.• Have good command on ISO 9001, ISO 14001, ISO 13485, ISO 15378, ISO 22000, ISO 17025, HACCP, SASO Quality Marks & ISO 14644.• technical Documentation of government Tender for different medical Products. • Defining and monitoring hygiene rules for the maintain Cleanroom environment• Enviromental Validation and Control of Clean room as per ISO 14644.• Maintaining a calibration scheme for laboratory equipment.• Oversees development & implementation of quality plans to examine and inspect the products during and after manufacturing process, review and approve instructions for the inspection.• Procurement and Verification of Quality Control Equipment.• GMP trainings and internal Audit of GMP Compliance.• Analyzing test and inspection results to identify potential causes of non-conforming product.• Internal Auditing (Process, System and GMP) as per ISO and Regulatory compliance to ensure compliance with all company policies and procedure and appropriate regulation and Standards including, SASO Quality Mark, ISO 9001, ISO14001, ISO 22000, ISO 13485 and ISO 15378.• Reviewing and implementation of system and process documents as per ISO and Regulatory compliance.• Coordinating in 2nd party and 3rd party Audits.• updating and review of technical files as per MDD and or MDR,product standards and ISO requirements.