Analytical Method Validation Specialist

We are looking for a Analytical Method Validation Specialist that will be responsible from the following processes:

• Ensure Health Authority requirements concerning the AS&T Department are fully met,
• Execute the main activities according to prepared SOPs and laboratory rules,
• Fulfill the responsibilities, which are given by leaders at the right time and correctly in conformance with methods, procedures and work flow,
• Following the global analytical method development studies, current guidelines and pharmacopeia,
• Routinely assess testing monographs and proactively sustain compliance of all activities with current official regulations, pharmacopeias, QM, QD, GOP and SOP,
• Evaluate and implement new technologies required to maintain state-of-the- art analytical methods for development and marketed products,
• Execute analytical method development, pre-validation and validation studies,
• Ensure right first time in all analysis and documentation,
• Prepare the related CTD documents of updated testing monograph.

QUALIFICATIONS 

• University degree in Pharmacy, Chemical Engineering or Chemistry,
• Minimum 2 years of Analytical Laboratory experience with equipments e.g. HPLC, GC, UV/Vis,
• Knowledge of cGMP& cGLP and basic SAP,
• Ability to work in a fast-paced changing environment,
• Team working and customer oriented mindset,
• Good analytical thinking skills,
• Strong interpersonal written and verbal communication skills,
• Good knowledge of MS Office applications,
• Good command of English is required,
• No military obligation for male candidates.

Aday Kriterleri

Pozisyon Bilgileri