Want to be part of a high performing team? We offer that.
Ready to invest in your career? We offer that, too.
Welcome to AbbVie!
At AbbVie, we offer you the resources and a global reach to empower your innovative mindset. From day one, we’ve known it takes teamwork and collaboration to develop the scientific breakthroughs, innovative pipelines, and therapies that change millions of patients’ lives around the world. In short, we know it takes “you” to make those ground-breaking advancements happen. We take pride in serving and supporting our communities and protecting the environment, making a lasting impact that's felt within healthcare and beyond
We are now hiring a Junior Qualified Person (all genders) to join our diverse Team in Ludwigshafen am Rhein.
You execute the Junior QP role for the very first time after initial registration as QP and are responsible to ensure high quality standards of AbbVie are maintained.
In addition to this you maintain site compliance to cGMP of all markets where products manufactured by the site are commercialised, and ensure compliance to AbbVie requirements, by building, monitoring and maintaining a sustainable site quality system.
In this function the responsibility is for batch release process and qualified person duties ensuring product has been manufactured under GMP conditions and in compliance to filed specifications. You act as the QP for the production, testing and distribution of marketed product pursuant to Article 14 of the AMG (German Medicines Act), Article 16 of the AMWHV (Regulation on the Production of Medicinal Products and Active Substances), Annex 13 and 16 of the EU GMP guidelines as well as all other relevant legislation and regulations.
So let’s tell you a little more about this role…
- Are complying with GMP regulations/corporate policies requirements and expectations while keeping updated on industry trends and regulatory bodies expectations / guidelines / regulations evolution.
- include assessing and providing directions on investigations, complaint reports, change plans and other GMP relevant reports, with respect to regulation/ policies compliance and with respect to patient impact; you review Product/Materials Specification, Test Protocols, Manufacturing instructions with respect to filed specifications and processes.
- Act as observer in audits and inspections.
- Act as observer and assist core team members in Product Action and Triage meetings.
- Have personal responsibility to assure and certify that supplies which are manufactured or imported into the EU under the responsibility of our Ludwigshafen site comply with regulatory requirements, are conform with regulatory submissions (IND, CTA, MA) and meet required standards of quality and safety.
- Are a Pharmacist.
- Have the Qualification as a Qualified Person according to German Drug Law and EU directive.
- Are articulating what is wrong, why, and how to resolve it across the cross-functional team.
- Show passion for performance and drive for innovation.
- Demonstrate a high degree of self-motivation/proactivity and efficient results-oriented way of working.
- Have excellent communication and presentation skills.
Are you ready now to be part of this innovative diverse team? Apply Now!
We are looking forward to your application. Please provide information about your salary expectations and possible start date in your motivation letter.
An equal opportunity employer. AbbVie welcomes and encourages diversity in our workforce.
Learn more about AbbVie Deutschland at www.abbvie.de. Visit www.abbvie-care.de for more information about the therapeutic areas in which we’re active.
Job Type: Temporary Work