The Quality Computer System Specialist will be responsible for administrative duties for computerized systems as well as assuring the design, installation, implementation, and data integrity computer systems at one of our Supply Site(s) meet all applicable industry standards and regulatory requirements.
Perform administration function for computer systems within the QC laboratory and manufacturing systems. This include laboratory instrumentation, GQLIMS, BMRAM and SAP as well as automated control systems.
Review qualification and periodic review activities for computer / control systems including the following documents: URS, DQ, IQ, OQ, PQ, and Trace Matrix.
Perform and/or support periodic review activities for QC computer systems including FT-IR, XRD, XRF, etc. Perform and/or support periodic review activities for manufacturing computer systems including such as BMRAM, Wonderware and SAP.
Manage changes and updates to the QC computerized systems.
Review the design and implementation of computer/control systems to assure that security and data integrity are maintained.
Support IT infrastructure qualification activities.
Analyze data and information to determine whether computer / control systems are within an appropriate state of control during qualification and validation as well as in assessing the need for requalification / revalidation on a periodic basis.
Prepare, document, and/or evaluate change controls for computer / control systems to ensure that they remain in qualified, validated state
Identify and investigate unusual or unexpected events, data, or sources of variation during the implementation and validation; assess and recommend disposition regarding the impact upon qualification or validation as applicable, and recommend appropriate corrective/preventive actions
Ensure that work is performed in accordance with applicable regulations, industry guidelines and practices, approved procedures and cGMP
Other responsibilities as assigned by department management
Education: Bachelor s degree in a science, technical, or engineering field
Experience: At least two (2) years experience in pharmaceutical or related industry with demonstrated knowledge of computer systems design, qualification, data integrity and validation.
Must have attention to detail. Work requires a high degree of accuracy in complex documentation.
Knowledge of computer system and control system design and validation concepts including GAMP.
Must understand concepts of qualification and validation as well as sampling, risk evaluation, and detection of variation.
Awareness of qualification of control systems and computer system validation (CSV) preferred.
Able to work cooperatively with other members of the Validation Team, Quality, and Manufacturing in the design and performance of qualification and validations.
Must effectively evaluate information collected from various sources and determine impact upon controlled state of processes, equipment, facilities, and products.
Excellent technical writing and verbal communication skills
Requires the ability to apply scientific and analytical principles for solving problems and proper design of qualifications and validations.
Working knowledge of cGMP and other applicable guidelines and regulations