IT Jobs in North Vernon, IN

our people's exceptional skills with those of people from all over the globe. IT/Computer Systems- Principal /Senior Compliance Specialist is responsible for providing both tactical and strategic leadership for ensuring GMP IT/Computer System compliance activities within operations.

The core responsibilities of the role are as follows: Manage critical IT/Computer Systems (Data Integrity) Compliance and QS programs and lead/execute required activities to ensure the site meets current GMP requirements of all local/global regulations and internal AZ Quality and Compliance policies. Drive continuous improvements efforts through monitoring/evaluation of site systems and processes against current

Compliance and Quality Systems requirements and influence key stakeholders on recommended Compliance improvements. Provide active support during inspections of site by External Customers, internal backssors, and Regulatory authorities.

Main Responsibilities: IT/Computer Systems Represent the Mount Vernon site as the Compliance Subject Matter Expert (SME) in GMP IT/Computer Systems including Data Integrity Compliance liaison for Digital projects related to GMP systems. Advance digital solutions in the GMP environment Challenge current GMP regulations with innovative digital solutions. Perform and support Data Integrity risk backssments of manual and automated GMP systems. Prioritize risks

and work with IT, QA, Laboratory, Automation, Manufacturing, and Warehouse personnel to mitigate IT/Computer Systems (Data Integrity) Compliance gaps.

Be current with regulatory requirements (FDA, EMA, MHRA) and applicable GMP regulations related to IT/Computer System.. backss and approve the compliance of proposed and existing software systems (Electronic Batch Records, Tulip, and other digital applications) that support manufacturing, warehousing, and the laboratory. Works with appropriate areas to mitigate gaps. Communicate with Local, Regional, and Global process owners to collaborate on IT/Computer Systems subject matters. Keep abreast of current GMP Trends relating to IT/Computer Systems including data integrity Lead a cross functional site Data Integrity team to assure site training sustainability and issue resolution Execute Astra Zeneca Business Process Management skills and use of the tools Exhibit leadership and communication skills for running governance networks and training courses Basic knowledge of GAMP categorization Collaborate with the local IT and Automation networks Understanding of GMP Documentation as it pertains to IT/Computer Systems Essential Requirements Bachelor's degree in a science/technical field such as Computer Science, shop, Biology, Chemistry or Engineering.

Excellent oral and written communication skills. Strong ability and motivation to learn. Ability to collaborate and participate in multi-disciplinary teams. 7 years industry experience. Experience with GMP IT/Computer systems Demonstrated ability to work independently and collaboratively on multidisciplinary and multifunctional teams. Strong familiarity with production operations. Strong leadership, project management, and technical writing. Strong interpersonal, communication, and influencing skills. Preferred Requirements: 7+ years in the medical industry.

Understanding and knowledge of Computer systems/Data Integrity GMP regulatory expectations Prior experience leading/managing regulatory inspections. Expert knowledge of global regulatory and c GMP requirements, industry best-practices. 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.

Astra Zeneca is an equal opportunity employer. Astra Zeneca will consider all qualified applicants for employment without discrimination on grounds of disability, interaction or interactionual 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. Astra Zeneca only employs individuals with the right to work in the country/ies where the role is advertised. Date Posted 21-Nov-2023 Closing Date Astra Zeneca embraces diversity and equality of opportunity.

We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics (e. g. race, color, religion, interaction, interactionual orientation, gender identity, national origin, disability or protected veteran status).

We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements. Astra Zeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.