Provides GMP, GDP, GCP and GLP services, auditing and training to pharmaceutical companies, biopharmaceutical companies, and medical device companies. Conducts as-needed audits for clients within the pharmaceutical, biopharmaceutical, and medical device industries. Audit types include APIs, Excipients, Biologics/Biotech, Cosmetics/OTC, Nutrition/Nutraceuticals, Sterile APIs, Human Tissue, Cell Therapy, Serialization, and Software.

Responsible for leading all International & Local GXP Audits, Inspection Readiness, Due Diligence Audits, Mock Regulatory Audits and Gap Analysis, Audit Remediation, Audit Partnership Activities

Responsible for leading Quality Assurance (QA), Quality Control (QC), Quality Management Systems, Validation, and Regulatory Compliance groups in support of Quality Academia Consulting & Engineering & Auditing Company. Leading a team of engineering, construction, auditing, quality management systems experts who support Quality Academia’s Global Business Operations.

Leads consulting practice offering Pharmaceutical & Biotechnology & Medical Device Quality Management System, Auditing, Training and Advising to Small, Medium and Large Pharmaceutical, Medical Device, Biotechnology companies to improve their Quality Management Systems & GXP, internal and external auditing programs to drive effectiveness and efficiency into organizations; aid in investigation/evaluation of manufacturing deviations and evaluation of corrective actions; prepare responses.

More than 3000 hours of GXP Audit experience for both Sterile and Non-Sterile Pharmaceuticals within Bayer HealthCare. As Global GMP Lead Auditor and Trainer responsible for preparing the whole factory to National and International GMP Audits. Lastly prepared the whole plant for a PIC / S Audit and helped the site pass GMP Audit / PIC Audit.

Responsible for leading starting materials quality controls with thlab. machines finally reporting directly to Head of Quality. In case of any malproductio of materials capable of rejecting these items. Writing SOP’s according to cGMP. and GQCLP, GWP, GDP procedures and documentation regulations, including raw-materials sampling procedures, sampling of primary and secondary packaging materials, warehouse procedures. Leading of Auditing Starting Materials Suppliers both Internally and Externally.

Responsible for raw materials, familiar with lab. instruments such as UV Viscosimeter, Polarimeter, pH Meter, Dissolution, Tablet Hardness Device, Melting Point Device, Densitometer, FT-IR, NIR, GC, HPLC. Organizing analytical tests of raw materials according to cGMP and GQCLP regulations & guidelines and completing the other tests required. Obtaining a certificate of analysis in order to make the product ready for release. Translating original documents from English into Turkish which relate

Responsible for Final Control Lab, in charge of checking semi-product, finished product directories which represent all the steps of manufacturing process. For semi-product in charge of checking product’s mark, shape, and color, for tfinished product in charge of checking product’s expiration date and price according to related directories. Obtaining certificate of analysis in order to make the product ready for releasing and reporting each step to Quality & Assurance Manager. Checking