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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