Associate Quality Assurance  Engineer 

The Company
Our client is an innovative leader in the field of pharmaceutical biotechnology. Over the past 40 years, they have been pioneers in developing revolutionary medicine to help ill people around the world.

The Role 
As an Associate Quality Assurance, you will be responsible for perform QA oversight for validation of equipment and packaging qualification, as well as perform review and approval of equipment validation documentation, ensuring that Corporate, Site and Regulatory requirements are met.
Provide quality support for testing strategies and quality investigations and perform review and approval of master data in the electronic batch record platform (PASX).

Responsibilities
- Reviews and approves validation documentation, Maintenance & Engineering support
- Reviews and approves changes to equipment. 
- Review and approved master data in PASX system as QA, as well as change control. 
- Performs final review of technical change controls, confirming assessments of different stakeholders are complete and all tasks are correctly represented in the record.
- Functions as QA SME and collects input from different QA areas to complete the QA assessment for technical changes.

Requirements
- MBO or Bachelor’s degree in Life Sciences or process technology related field or the equivalent combination of education and/or experience.
- Typically 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 language

Other information
Are you ready to the next step in your career? Feel free to contact me or apply below. 
 

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