işıl kalay

*  To direct, follow and control routine production operations in the direction of the program. *  To take part in the implementation of the documentation system, to cary out and follow the training of the laborer. *  Carry out weekly planned productions. *  Follow-up and documentation of the deviations and damages that occur. *  Control and approval of MBRs. *  To follow solid production processes. *  To ensure that the production conforms to GMP rules and performs expected performance

*  Develop and validate analytical test methods for the testing of pharmaceutical products and cleaning verification, ICH Q2 requirements. *  Follow up the EP, FDA, BP in terms of any change in monograph or drug-administration procedures and implement them. *  Write / review analytical method development, validation, transfer protocols and reports. *  Conduct investigations and write analytical investigation reports. *  Write / review specifications and methods. Write / review Standard Operating Procedures. *  Solve complex analytical chemistry problems. *  Provide analytical support and expertise to the team and other departments *  Collaborate and transfer robust analytical methods to QC labs. *  Plan and organize daily and weekly programs *  Contribute to and review analytical methods *  Supervise, motivate team members *  Ensure good relationships and collaboration with all other teams in QC, operations, QA, Regulatory Affairs etc.