Nucleic Acid Isolation from bacteria
Restriction digestion of plasmid
PCR and qPCR
Protein isolation and SDS PAGE
Western blot and Southern Blot
Human Anatomy and Physiology, Analytical chemistry, Pharmacology, Pharmaceutics, Dispensing Pharmacy, Organic chemistry, Medicinal chemistry, Biochemistry, Microbiology.
•Worked under close supervision of regulatory affairs manager to conduct auditing activities and ensure compliance meeting with strict deadlines.
•Analysis of raw material and final products.
•Responsible for report writing and tracking database of audit schedules and results.
•Ensured that all regulatory documents are compliant with Standard Operating Procedures (SOPs) or not.
•Assist in developing and modification of SOP manuals and in maintaining FDA compliance.
•Educated staff in quality improvement methods also participated in educational activities and programs about GCP, ICH and FDA guideline compliance training.
•Attended regulatory staff meetings on regular basis
•Contributed to development of SOPs, guidelines and policies.
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