Abdullah Sandıkçı

Assisting the clients to comply with with relevant regulations, including FDA, EMA, and other global regulatory standards. Develop and implement compliance programs and policies. Additionally ensuring the integrity and security of data across all processes. Implement data governance frameworks and conduct data integrity assessments. Conducting CSV - CSA to their GxP systems to have compliance.

Supporting manufacturers in the design and implementation of manufacturing and laboratory digitalization and IT projects to achieve their compliance and productivity goals in regulated GxP environments.

+ Planning, organizing, managing and reporting validation activities in scope of EU Annex11, 21 CFR Part11, GAMP5 and local regulations + Documentation – writing, maintaining, reviewing and updating validation documentation, and approving validation SOPs; + Reviewing validation data, compiling reports and contributing to internal audits and external inspections as they arise;

Following up and controlling contract manufacturings, technology transfer studies Controlling production and quality control analysis documents and preparing release reports of productions Controlling raw material certificates, production and filling protocols Controlling and giving version codes to artworks Archiving customer complaints and preparing trend analysis Providing ISO13485 necessities to QMS in the firm

Helping users to overcome their problems about equipment or software using./ Helping customers to adapt their existing technologies into our products./ Performing technical/ product training to users in customer's site./ Resolving customer's issues or difficulties in the usage of the instruments./ Specifying analysing methods, SOP's in accordance to the ISO, Pharmacopoeias or in house quality regulations./ Working with sales team to show full efficiency of instruments

Applying analytical method transfer studies and preparing of its protocols and reports. Evaluating conformity of results with the licence holder companies. And also applying analytical method development studies in the need of company. Applying ICH, cGLP guidelines on my work. Applying PQ and calibration tests to analytical instruments just like HPLC's, UV Spectrofotometers' , balances, etc.

Analysing,reporting finished products for pharmaceutical company in the guidelines of cGMP, cGLP, related SOPs. Applying related methods efficiently. Furthermore applying process validation analysis.

İş aramaktayım. / Looking for a job

Attended as a Work and Travel Student Program

Process Design, Process Control, Mass- Heat Transfer, Basic Engineering Knowledge

Basic High School Education with 1 year English education