SYNGENE Career Opportunities:
Associate Scientist-Quality and Compliance, DMPK M.Pharmacy
Key Responsibilities:
Review, document, and report
all raw data, experimental procedures, documents and results according to GxP.
Conduct QC review of
departmental log books, equipment and instrument logs, equipment and software
installation and validation documents, solution-reagent labels, reference
standards, and controlled substances inventories.
Support Regulatory Authority
Inspections and Sponsor Audits.
Assist team to ensure compliance
to SOPs, suggest SOP revisions when applicable, and ensure reported and/or
identified deviations to SOPs are properly documented in Study Report.
Maintain the proper level of
regulatory compliance for each study, helping to address QA audit findings.
Maintain tools, computer
programs, and SOPs required for studies.
Educational Qualification:
M.Pharmacy
Technical/functional Skills:
Understanding of DMPK related
activity and instruments like Mass spectroscopy, HPLC, added advantages with
the experience on Automation.
Expertise in preparation of
DMPK related SOPs (study as well as instruments).
Experience:
Relevant experience of 3-6
years post qualification is required.
TO APPLY CLICK HERE
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