-Highly skilled and experienced laboratory professional who contributes by performing analytical release testing, investigation support, research support, and stability testing.About the RoleMajor accountabilities:CAPA definition - KPI trending - Ensure all activities in compliance with cGxP, incl. data integrity review and approval of analytical data / tests (analytical release) Stability - Stability testing (Projects) – protocol preparation, evaluation, report preparation.Review and approval of analytical tests (analytical release) - Microbiological QC - Perform Microbiological testing of materials and utilities, environmental and personnel monitoring.Collaborate and act actively on the housekeeping program, maintaining the lab clean, organized, standardized, identified according to 6S methodology;Key performance indicators:The relevant KPIs that are defined in the Quality Control areas apply: e.g. analytical lead times - Timely and GMP-compliant analysis & documentation of the results.Error rate: Number of OOS (analysis errors) related to the number of analyzes - No complaints about official inspections.Individual performance is assessed using the PMP performance dialog together with the manager.Work Experience:A bachelor's degree related to the Pharmaceutical area, Chemical or Biological, titled with a professional license.3+ years experience in Pharma/Manufacturing sector in analytical lab.Skills:Continuous Learning, Dealing With Ambiguity, Decision Making Skills, Industry Standards, Quality Control (Qc) Testing, Self Awareness and Technological Expertise.Solid knowledge in Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP) and GDocP.Knowledge in current pharmacopoeias such as USP, EP, BP, JP, etc. local and international requirements.Knowledge of local, regional and international regulatory standards, such as ANVISA, ICH, FDA, EMA, ANMAT.Extensive experience in physicochemical analysis of finished product.Knowledge in quality system, such as change control, deviation investigation, OOS, OOT and OOE in the laboratory.Knowledge in data integrity principles (ALCOA+).Solid knowledge in chromatographic analytical techniques such as: UV/Vis spectrophotometer, dissolution, HPLC, GC and MS-LS. And software such as Empower.
#J-18808-Ljbffr