Posted on 1/9/2019
Review qualification requirements for any new instrument and process with system owner and cross-functional team. Prepare protocols and reports related to equipment/system/utility qualification (IQ/OQ/PQ), engineering, process and cleaning validations. Execute protocols and related activities associated with validating equipment, systems utilities, processes, transferring new products/processes from R&D to manufacturing and executing processes/documentation improvements. Preparation, execution, and review of laboratory equipment validations. Initiate and investigate protocol deviations and coordinate follow up with QA. Coordinate with a cross-functional team for internal and external audits.
Batchelor's Decree in Microbiology or equivalent.
Knowledge of cGMPs
Knowledge of Validation Guidelines - SOPs, FDA, ICH, EU, MHRA, OSHA, DEA, and MSDS guidelines and requirements
Interpret and develop documents such as Site Master Plans, Validation Master Plans, Validation Protocols, Technology Transfer Documents, Master Production Records, Operating and Maintenance Instructions. and Procedures Manuals.
103 Beaver Court
Cockeysville, MD 21030
Pharmaceutics International, Inc.
Attn: T. Kane
10819 Gilroy Road
Hunt Valley, MD 21031