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QUALIFICATIONS AND JOB DESCRIPTION
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.
30 Nis 2024;
from:
kariyer.net