Analytical Method Validation Specialist

SANDOZ GRUP SAĞLIK ÜRÜNLERI İLAÇLARI SANAYI VE TICARET A.Ş.

•3-5 years Analytical experience
•Good command of English
•Have good computer skills
•Have enough GMP comprehension, ability and experience that is needed to perform activities are responsed correctly and effectively
•Strong communication, time management and priority setting skills
•Have analytical mindset
•Team player

İŞ TANIMI

•Performing main activities according to the SOPs prepared and GMP rules
•Using valid and approved test and analysis methods in the department where he/she works.
•Testing for new product, analytical regulatory needs and AMT workings of laboratory analyzes in right time and right way.
•Testing for Analytical Method Validations and Verifications analyzes in right time and right way.
•Preparing Protocol and Report for Analytical Method Validations and Verifications.
•Recording analysis results to forms that is used clean and in order to use his/her time effectively, control, sign and deliver to the Team Leader on time.
•Work providing the health and safety of himself/herself and also his/her co-workers
•Keeping the equipment clean and controlling qualification labels and dates of devices used.
•Calibrating daily calibrations related to used devices and record to the logbooks.
•Protecting privacy of methods and documents used and do not any corrections or addition in original documents, do not copy, work according to record management principals appropriately
•Preparing reagents that is used in laboratory and record to solution logbooks
•Signing the results obtained from used devices and documented them tidily. All data are recorded on logbooks.
•Perform the non-routine analyses like stability, cleaning validation and research given by Team Leader.
•Contributing to saving projects intended for decreasing the cost of production and product
•Developing projects intend for increasing labor force and machine efficiencies and work in pairs with related to the Teams
•Contributing to provide total quality culture with high performance approach.
•Performing necessities related to HSE about all local regulations and Sandoz rules, join trainings and follow the rules
•Carrying out all of the requirements of an analysis (OOS investigation, etc.)
•Supporting documentation and take role all documentation processes
•When necessary, revise test plans and details which approved with SAP system under control with