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Senior Talent Acquisition Specialist @ Cognizant | HR, Recruitment
About the Company:
The CSV Engineer will be responsible for ensuring our existing Computerised Instruments remain in a validated state and that data integrity controls are implemented to ensure ongoing compliance with global Quality Standards and Practices. They should have experience in System Administration, Technical Writing, and Document Management. Experience in pharmaceutical API manufacturing is desirable.
The role involves working within a collaborative CSV team and requires excellent communication and interpersonal skills, with the ability to work independently.
* Minimum 3 years experience as User/System Administrator on IT/Lab applications
* Minimum 3 years experience of technical writing in a regulated environment
* Good knowledge of cGMP to understand site quality systems
* Experience in implementing changes for Lab systems in a GMP environment, including analysis, configuration, and documentation updates
* Strong communication skills, with the ability to build cross-functional relationships
* Attention to detail and accuracy
* Ability to meet deadlines
* Self-motivated, organized, and good at time management
Key Responsibilities:
* Review system audit trails and reconcile with system changes and activities
* Apply critical thinking to identify controls that ensure data integrity and compliance in GMP manufacturing, maintaining data completeness, consistency, and accuracy
* Modify and review CSV and compliance documentation, including design, configuration specs, SOPs, templates, test cases, and change controls
Additional duties include:
* Managing Computer System Validation documentation in line with Quality Standards, working with System Administrators, SMEs, and QA
* Executing test scripts, analyzing results, and assessing acceptability against criteria
* Collaborating with the business to implement procedural controls to address testing issues
* Leading procedural improvements to enhance validation efficiency and consistency
* Supporting and participating in site audits
Seniority level
* Mid-Senior level
Employment type
* Full-time
Job function
* Engineering, Information Technology, and Quality Assurance
Industries
* Pharmaceutical Manufacturing, Medical Equipment Manufacturing, Biotechnology Research
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