Your new company

Your new role

• Process, equipment and IS validation
• Agree on strategy and provide guidance regarding design, characterisation and validation in cooperation with PD / M&E / IS, while ensuring GMP quality and compliance.
• Reviews approve validation documentation and changes to equipment (e.g. parameter changes, like for like assessments, …)
• Maintenance & Engineering support.
• Device and product combination
• Manages ABR’s device responsibilities and ensures alignment with GMP regulations.
• PASX master data, change control.
• Review and approved master data in PASX system as QA.
• Performs a final review of technical change controls, confirming assessments of different stakeholders are complete, and all tasks are correctly represented in the record.
• Function as QA SME and collects input from different QA areas to complete the QA assessment for technical changes.
• Deviation management.
• Function as a QA contact for deviation records.

What you'll need to succeed

• An MBO or Bachelor’s degree in Life Sciences or process technology related field or the equivalent combination of education and/or experience.
• 3 years of relevant experience in the pharmaceutical or medical device industry with experience in Equipment and Automation Validation.
• Good Manufacturing Practice (GMP), equipment and automation/IS validation, computer compliance (Annex 11, Part 11) knowledge with the ability to interpret and apply in mainly routine cases.
• Manufacturing and/or Quality analytical processes and operations.
• Fluent in English.
• Logical and linear analytical skills to evaluate and interpret complex situations/problems using multiple sources of information.
• Good understanding of quality engineering tools.
• Teamplayer, constructively working together towards solutions.

What you'll get in return

Hays Detachering | This is a project that will start with a contract for Sr associate QA through Hays. In this position, you will get a competitive salary and your travel expenses are covered.

What you need to do now

If you are interested in this role, click ‘Apply now’ to send an up-to-date CV, or give us a call! Is this job isn’t quite right for you, but are you still looking for a new position? Please contact us for a confidential discussion about your career.