Must have Masters degree or U.S. equivalent in Chemistry, Pharmaceutical Chemistry or Pharmaceutical Manufacturing. Must have 2 years of experience in pharmaceutical quality assurance. Experience must include performance of routine inprocess QA activities such as compounding, filling, sealing, optical inspection reconciliation of stage wise yield; in Batch Production and Controlled Record BPCR entries; and in root cause analysis, corrective, and preventive actions CAPA to support investigations. Must have experience in manufacturing process of sampling of formulation filling, yield reconciliation inprocess checks, sampling details, line clearance, validation. Must have demonstrated experience in ICH guidelines, FDA regulations, Standard Operating Procedure SOP, cGMP record, environmental protection, change controls deviations. Applicant must have experience facing audits and preparing respective compliance reports.
Categories: eb3
0 Comments