Cognizant is a world leader in delivering digital transformation solutions to Life Sciences. Through our knowledge and expertise in Automation, MES & Digital, we deliver stable manufacturing systems that are optimized to improve operational efficiencies, whilst maintaining compliance.
Our specialist engineering teams have the aptitude to deliver and support Pharma 4.0 architectures and solutions covering all IT, OT and IoT applications, infrastructures and services.
Operating across 5 continents and with over skilled employees, Cognizant partners with the leading Life Sciences companies globally to provide performance improvements, reduced costs and improve time to market. We are your single end to end partner for consultancy, design implementation, optimization and support for all applications in the Pharmaceutical and Biotechnology Manufacturing stack.
We're looking for dedicated, innovative and driven talent to join our expanding IT Computer Systems Compliance team in Cork.
Overview:
The IT Computer Systems Compliance Engineer will be responsible for on-going IT application and compliance support within the IT Team of local and globally managed computer systems and will need to have experience in implementing and supporting IT applications, technical writing, and document management in a regulated environment.
The IT Computer Systems Compliance Engineer will need to have a strong quality background to maintain quality standards in a GMP environment. The position will work within a collaborative IT team and will be required to have excellent communication/interpersonal skills with the ability to lead projects and work on their own initiative as required.
Experience of working in a pharmaceutical manufacturing operation is desirable.
Responsibilities:
* Generate computer system validation documentation in accordance with site procedures and GMP guidelines
* Modify and Review existing CSV & Compliance documentation (e.g.Standard Operating Procedures, templates, strategy documents) focusing on continuous improvement and following up on gaps or discrepancies
* Lead procedural improvements that will increase efficiency and consistency of the validation process
* Work directly with System Administrators/Subject Matter Experts and Quality Assurance Representatives ensuring ongoing compliance with Quality Standards and Practices
* Introduction of new IT systems
* Privacy, Data Integrity and System Audit trail assessments for IT systems
* Perform Security Reviews and Periodic Reviews for IT systems
* Communicate with stakeholders to understand and clarify software requirements
* Support of ServiceNow, SharePoint and IT applications
* Execute test scripts, analyze test results and determine the acceptability of results against pre-determined criteria
* Work with the business to identify and implement procedural controls to mitigate issues found during testing
* Maintain tracking system for compliance actions and provide bi-weekly updates
* Support and participate in site audits.
Requirements:
* 5+ years' Compliance experience with Data Privacy, Data Integrity, IT Service Management (ITSM) and Information Security for computer systems
* Knowledge of ServiceNow, Windows servers, SQL databases is an advantage
* Knowledge of GxP (GMP, GDP)
* Attention to detail and accuracy
* Ability to meet deadlines
To apply for this onsite, full-time IT Computer Systems Compliance Engineer role, please contact Cognizant today. Please refer any friends or colleagues for this role or direct them to our Careers page on our website.
At Cognizant, we engineer modern businesses to improve everyday life because we're dedicated to making a lasting impact. Cognizant (Nasdaq: CTSH) engineers modern businesses. We help our clients modernize technology, reimagine processes and transform experiences so they can stay ahead in our fast-changing world. Together, we're improving everyday life. See how at or @cognizant.