Your new company

Your new role

This role will report to the quality manager and will work with the QA department. The role will be to assist in delivering team key objectives and goals.
• Assist with validation documentation preparation and execution.
• Support site commissioning and development and manufacturing projects through the generation and execution of validation activities.
• Ensure validation tasks comply with accepted practices and quality standards to meet the performance objectives of the department.
• Champion the requirements of annex 11/21CFR part 11 to help the site meet GMP objectives.
• Perform/support periodic reviews of the validated state of systems.
• Complete all other tasks as requested by your supervisor from time to time that may not fall within the stated scope of this role.

What you'll need to succeed

• Tertiary qualified in science related field

• Experience working in Validation

• Formal experience in computer systems

• PIC/S Annex 11 Computerised Systems and Annex 15 Qualification and Validation

• 21CFR Part 11 Electronic Records; Electronic Signatures

• GAMP5

• ISO13485

• 21CFR Parts 210 and 211

• PIC/S Code of GMP

• Quality Management Systems (QMS)

What you'll get in return

What you need to do now

If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.

If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.