Validation Supervisor
CurrentOversee subordinate functions. Advise /support multi-site cleaning programs. Coordinate activities in-house and contract laboratories. Interface with various departments in delineating project management/ load matters. Provide training to key QA personnel on sampling procedures who in turn, educate their staff. Design, implement and maintain company’s cleaning program to current industry practice from both a chemical (APIs, cleaning agents) and microbiological (environmental monitoring) perspective. Review /author SOP’s governing the cleaning platform, as well as, those pertaining to the operation, cleaning, preventative maintenance and calibration of process /packaging equipment.Acquire surface area dimensions of process /packaging machinery either by manually calculating or requesting from vendor as part of sample scheme creation along with illustrations that identify swab site locations. This representative sampling measures the degree of cleanliness attained for articles tested. Swab site selection is based on, but not limited to experience, configuration, hard to clean equipment locations, testing results. Establish therapeutic and health risk based acceptance criteria for API and cleaning agents. Maintain electronic database of cleaning projects (eg. protocols, reports)Evaluate procedures used to clean equipment required for oral-solid dose pharmaceutical, manufacture. Also, assess manufacturing processes of same. Review /Approve cleaning validation, process validation and stability protocols. Interpret data then, deliver respective technical reports. Active participation in company sponsored seminars/ workshops concerning the pharmaceutical industry.