وظائف شاغرة | مطلوب كيميائيين للعمل لدى أدوية الحكمة - Scientist, Analytical Research

Job description:

Auditing and Approving the method validation report and protocols generated by Hikma Columbus QC bench lab located in Hikma Jordan, including extractables/leachables and pharmaceutical impurity identification using advanced mass spectrometry techniques including LC/MS and GC/MS.
Auditing and Reviewing the deviations and investigations generated by Hikma Columbus QC bench lab located in Hikma Jordan.
Auditing and Approving the maintenance reports for the instruments related to Hikma Columbus QC bench lab located in Hikma Jordan, including extractables/leachables instruments such as advanced mass spectrometry techniques including LC/MS and GC/MS.
Auditing the electronic data generated from Hikma Columbus QC bench labs. including extractables/leachable and pharmaceutical impurity identification using advanced mass spectrometry techniques including LC/MS and GC/MS.
Follow up the Training of Hikma Columbus QC bench labs.
Conducting internal Audits and preparation for external Audits.
Reviewing and updating the SOP/System related to Hikma Columbus QC bench lab.

Role and Responsibilities

Reviewing the generated reports and protocol against SOP’s, guidelines
Checking that all data transferred correctly to the reports.
Checking that all transferred data are correct and within the acceptance criteria.
Checking electronic data against the reported data.
Ensure that the analytical procedures developed in the laboratory conform to current and appropriate scientific, compendial and regulatory standards, and are suitable for use for their intended purpose.
Set a proper CAPA and risk assessments for the generated deviations and failures
Follow up the latest updates in the guidelines, pharmacopeia, FDA guidance’s
Auditing training files.
Provide training, technical expertise and support to the analytical staff.
Identify opportunities for quality enhancement and operational efficiencies and develop efficient methodologies to track the progress.
Evaluate new or state-of-the-art technologies for potential use in characterization and assessment of key drug product attributes.
Perform duties with a high level of independence.
Preparing for internal and external Audits.
Set response for external Audit observations

Basic Qualifications

Strong background in organic analytical chemistry, including organic structure elucidation of small molecules by mass spectrometry.
Have good experience on a modern mass spectrometry laboratory containing both advanced GC/MS and LC/MS instrumentation, including responsibility for up to 4 modern mass spectrometers and supervision/training of staff.
BSc degree in chemistry (organic chemistry or analytical chemistry) with strong experience in chromatography, mass spectrometry (LC/MS, LC/MS/MS, GC/MS) and other spectroscopic techniques. Ten+ years of experience in a mass spectrometry laboratory, either in the pharmaceutical industry or another appropriate setting.
Strong written and oral communication skills, English language, and the use of MS Office (Word, Excel) are required.
Have good experience in the quality system and reviewing data.

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