Education: University Degree in Chemistry or a related science. Preferred: MSc or PhD in Chemistry or a related science is preferred
5 Years Laboratory Experience in the related field
In depth knowledge of:
Method validation fundamentals and requirements
Solid understanding of pharmaceutical formulation and material characterization
Technical requirements as per compendia (USP/NF,BP/EP), in- house methods and general QC laboratory procedures
Analytical laboratory equipment common in QC Lab environment (HPLC, UPLC, GC, Dissolution & Particle Size etc.).
Knowledgeable in ICH guidelines, GMP/cGMP regulations as they apply to the laboratories.
Demonstrates excellent written and verbal communication skills in order to:
Interpret analytical data and discuss the issues/problems with the supervisor and peers if required.
Write in a lucid format, General lab procedures, SOPs, validation/method transfer reports and other relevant QC documents
Good computer skills with proficiency in Microsoft Office, Labware LIMS, SAP, navigating online compendia publications,
Good knowledge of QA business processes and RA business processes. Good understanding of:
Analytical methods and techniques common to QC Lab
GMP, cGMP and other regulatory requirements
Key measurements to support business related to customer service