Job Description:
Primary function is the timely and efficient advanced review ensuring accuracy, completeness and compliance to in–house, customer and regulatory requirement, including data integrity, are met following the testing of pharmaceutical starting materials, components and finished products using techniques such as manual/automated titrations, UV, FTIR, LOD, Karl Fisher, HPLC, GC, TOC, Water activity and Pharmacopoeial testing i.e. LOD, RI, ID, Limit tests, Review of raw data generated for stability testing, release testing, cleaning verification and method transfers. Training of personnel in data review in area of expertise, including mentoring and coaching. Author OOS investigations, determination of root cause and develop and implementation of corrective and preventative actions. Author investigations into deviations from defined procedures. Review of regulatory bodies for changes applicable to the laboratory and ensuring that any changes are implemented. Maintain metrics with respect to area of responsibility. Write, review, and revise work practices, and test methods. Review and approval of stability protocols, Review and approval of method transfer protocols and reports. There are no supervisory responsibilities.
