CSV Audit Trails

at  Cognizant

The CSV Engineer will be responsible for ensuring our existing Computerised Instruments remain in a validated state and while also ensuring data integrity controls are implemented to ensure ongoing compliance with global Quality Standards and Practices. S/he will need to have experience in System Administration, Technical Writing and Document Management. Experience of working in a pharmaceutical API manufacturing operation is desirable.
The position will work within a collaborative CSV team and will be required to have excellent communication/interpersonal skills with the ability to work on their own initiative.

DESIRED BACKGROUND/EXPERIENCE/ATTRIBUTES:

• 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 required to understand the quality systems on site.
• Experience implementing changes for Lab systems in a GMP environment would be an advantage e.g., analysis/configuration and updating Computer System Validation documentation.
• Strong oral and written communication skills are required, with proven ability to communicate and build relationships cross-functionally.
• Attention to detail and accuracy.
• Ability to meet deadlines.
• Self-motivated, detail-oriented, and excellent organizational and time management skills.

• Review system audit trails & reconcile to system changes and pre-determined activities.
• Apply critical thinking to identify specific controls to ensure data integrity/compliance in the GMP Manufacturing environment, to ensure the data is complete, consistent, accurate throughout its lifecycle.
• Modify and Review existing CSV & Compliance documentation for Lab systems and IT systems (e.g. Design, Configuration specs, Standard Operating Procedures, templates, strategy documents, test cases, change controls).

Work with existing team members in respect of ongoing projects in relation to the following:

• Ownership and responsibility of Computer System Validation documentation in line with Quality Standards and Practices working directly with System Administrators/Subject Matter Experts and Quality Assurance Representatives.
• 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.
• Lead procedural improvements that will increase efficiency and consistency of the validation process.
• Support and participate in site audits.