Türkiye
I have over 5 years of experience in pharmaceutical industry. I have been working in global pharmaceutical companies. My main experiences are pharmaceutical engineering, developing and improving manufacturing process, validating processes and preparing MBR's, validation procotols and reports according to GMP, ICH, FDA guidelines. Beside that, I have technology transfer, bulk holding time study, risk assessments, change control management and customer relations experiences. In my job experince, I am contact person to run projects and manage the controls with contracted companiest.
- Coordinating technology transfer projects from donor site, -Performing validation studies in scope of improvement request from production department (e.g. batch size changing, equipment changing), - Performing required trial works for alternative supplier related to raw materials of the products currently in production and ensures preparing required documents for the variation - Performing and participate to studies about product variations, or developing primer packaging material (eg. package, bottle, cover) functions for use in production, and decreasing the costs of products. If needed carrying out packaging qualification studies, - Executing the development and improvement studies upon the production methods, - Performing reprocess / rework studies, - Preparing related regulatory submission documents, - Attending on validation productions and following analytical results. Before and after productions preparing documentation of validation study, - Participating in Internal and External audits for the topics concerning own departments and to ensure preparation of required, - Answering the questions coming from authorities and Ministry, about the products in scope of portfolio maintenance in his responsibility, - Working on stability problems which have occurred in current products and which don't require change in formulation, - Solving unexpected problems occurred during validation productions, - Preparing production methods and keeping in production updated, - Coordinating the bulk product hold time studies according to plans and protocols, and to determine the bulk product hold time according to results, - Preparing related change control.