Senior Qualified Person (QP) Quality Assurance
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Pharmaceuticals
Frederikssund
Black Swans Exist | Recruiting talents for life science companies
You want…
a crucial position where you take on the responsibility for maintaining and continuously improving an effective Quality Management System (QMS). As a highly motivated professional, you want to ensure regulatory compliance and oversee batch releases. You are dedicated to creating safe and effective adjuvants for use in vaccines and want to be part of a world-leading organization.
You will…
work with the Quality Assurance leadership team to set directions and drive changes and improvements in the Quality processes, with a focus on investigational medicinal product (IMP) and Contract manufacturing organizations (CMO). In addition, you will continuously improve the QMS by engaging in ongoing follow-up on quality performance and KPIs, quality management review, and periodic quality review processes. You will use your expertise to collaborate with stakeholders to ensure the release of products with very high release schedule adherence. As Senior QP, you will oversee delegated QPs, and the batch review processes as well as attending board meetings with production and delegated QPs. Additionally, you will provide quality support to stakeholders, including active engagement in the more complex quality issues across the organization and participation in deviation, Corrective and Preventive Action (CAPA), and change control handling. Participation in inspections from authorities and audits from customers will also be part of your responsibilities. Furthermore, you will give input to quality agreements and self-inspections and will contact authorities concerning GxP authorizations and quality matters.
You’ll join…
a passionate quality department that works together to set a high standard for collaboration across the organization. The team is dedicated to keeping the world safe and is passionate about driving change. You will be part of a world-leading adjuvant specialist organization that operates across 37 countries.
You have…
- A Bachelor’s or Master’s degree in Pharmacy, Chemistry, or a related field
- At least 7 years of experience in a Quality Assurance role in the pharmaceutical industry, with experience in the QP role.
- Strong knowledge of pharmaceutical aseptic manufacturing processes, regulations, and guidelines.
- Proven ability to set directions, drive changes, and improvements in Quality processes.
- Experience with complex quality issues, deviation handling, CAPA, and change control.
- A strong attention to detail and ability to work in a fast-paced environment.
- Experience with inspections and audits from regulatory authorities and customers.
- Excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams.
Contact
If you want to hear more about this opportunity and the company, or if you have any questions regarding the position, please do not hesitate to contact us. If you wish to apply for the position, please send an updated version of your CV, together with what questions you might have, and we will get in touch with you soon.