At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people's exceptional skills with those of people from all over the globe.
The Quality Computer System Specialist will be responsible for helping to assure the design, installation, implementation, data integrity and validation of computer systems at the Coppell, Texas site meet all applicable industry standards and regulatory requirements.
* Ethical conduct and compliance
* Review, prepare and perform qualification and periodic review activities for computer / control systems. Analyze collected data against pre-determined criteria, and prepare final reports in compliance with relevant regulations, industry practices, and AZ policies and procedures
* Coordinate validation and implementation of computerized laboratory instrumentation
* Review the design and implementation of computer/control systems to assure that security and data integrity are maintained
* 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
* Oversight of IT procedures to ensure compliance and consistency within the AZ Pharma GMP environment
* Ensure that work is performed in accordance with applicable regulations, industry guidelines and practices, approved procedures and cGMP
* Other responsibility as assigned by department management
Education, Qualifications, Skills and Experience
* Bachelor's degree in a science, technical, or engineering field
* At least 3 years' experience in pharmaceutical or related industry with demonstrated knowledge of computer systems design, qualification, data integrity and validation
* Computer system experience with QC laboratory equipment. Empower and GQCLIMS preferred.
* 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
* 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
* Awareness of qualification of control systems and computer system validation (CSV) desired
Next Steps - Apply today!
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience - it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.
AstraZeneca is a global science-led biopharmaceutical company specializing in the discovery, development, manufacturing, and marketing of prescription medicines.