Senior QA Specialist – HAYS – Haarlem

  • Haarlem


Haarlem | Senior Quality Assurance Specialist | External Quality | Product Release | GxP
Your new role
In this role you will be the right hand of the QP and report to the Director of External Quality. You will be responsible for ensuring the compliance of all products managed by the External Quality meet the company’s standards and all the necessary regulatory requirements from manufacturing to distribution. More specifically, you will ensure compliance with with validated company’s procedures and governmental regulations (GMP, etc). You will be accountable for product release; review and approve batch record changes or methods/specification with regards to manufacturing compliance. You will be liable for the completion, analysis and report all all metrics such as trend identification and root cause. As the Assistant QP, you will supervise the quality of product release at the External Entity. You role is to keep the overview for Quality Control functions like product testing and other applicable components such as batch record review and deviation investigations. Your goal is to maintain and provide improvements in the QMS, tools and processes related to External Quality. Moreover, you will ensure permanent audit readiness, regulatory inspection support and monitoring, effective complaint management, change control oversight, metric review, and review of annual product reviews.
What you’ll need to succeed
You have strong educational scientific background (e.g. BS/MS Biology, Microbiology, Pharmacy, Chemistry,
Chemical Engineering or equivalent preferred). You have minimum of 5 years of relevant experience in pharma or biotech industry with a thorough knowledge of Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP and regulatory requirements. Must have strong interpersonal, communication, coaching, motivation, negotiation, and persuasion skills to build strong relationships
You enjoy working across boundaries; you pursue demonstrated interpersonal, relationship building
and leadership skills. Experience with external partner oversight is a plus. being registered as EU Qualified Person is a plus.
Your new company
Our client is driven by the purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, they offer state of the art laboratories, plants and offices that are designed to Inspire their employees as we learn, develop and grow in their careers. They are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. Our client encourages their employees to respectfully challenge one another’s thinking and approach problems collectively.
What you’ll get in return
Hays Detachering | This is a project that will start with a contract for 1 year through Hays. Extension to stay within the department is anticipated. At this position, you will get a competitive salary and your travel expenses are covered.
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 on your career. #1045127

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