Job Reference: FRS56575
Job Duration: 12 Months
Start date: ASAP
Description:
Ensure ongoing compliance with global quality standards and practices while maintaining the validated state and data integrity of our Computerised Instruments. Experience in System Administration, Technical Writing, and Document Management required. Pharmaceutical API manufacturing experience desirable.
Responsibilities:
* Review system audit trails, reconcilewith system changes and activities.
* Identify controls for data integrity/compliance in the GMP Manufacturing environment.* Modify and review Computer System Validation & Compliance documentation for Lab and IT systems.
* Collaborate with teammembers on ongoing project
* Ownership of Computer System Validation documentation, aligning with Quality Standards.
* Execute test scripts, analyse results, and determine acceptability.
* Implement procedural controls to mitigate testing issues.* Lead procedural improvements for validation efficiency and consistency.
* Support and participate in site audits.
Qualifications:
* Experience as User/System Administrator for IT/Lab applications.
* Experience in technical writing within a regulated environment.
* Good knowledge of cGMP for understanding site quality systems.
* Experience implementing changes for systems in a GMP environment is advantageous.
Industry: IT
Salary:
Salary Benefits:
Vacancy Type: Permanent
Job Skills: IT, Documentation, CSV
Contact Name: Fergus Kennedy
Website: -
Direct Application URL: -