Get 360Pharma
Qualified Person (QP) - Quality Assurance
Get 360Pharma, Sauk Trail Beach, Wisconsin, United States
Qualified Person (QP) - Quality Assurance
Apply now About the vacancy
R&D Drug Development Quality Quality Control Quality Assurance Compliance Regulatory Affairs Regulatory Affairs Regulatory compliance Submissions Clinical R&D Pharmacovigilance Engineering Quality Expert Bachelor’s Degree (HBO, WO) Permanent Full time Ghent, Gent, Belgium About Your Next Job
We are looking for the best talent for a Qualified Person – Quality Assurance for the CAR‑T hub to be in Ghent Belgium! Purpose:
CAR‑T (chimeric antigen receptor T‑cell therapy) is an innovative approach to eliminate cancer cells, which work by harnessing the power of a patient’s own immune system. They are created from the patients’ own T cells and are engineered to eliminate cancer cells expressing a specific antigen. To support the CAR‑T program in EMEA, J&J has built two CAR‑T manufacturing centers in the Ghent area (Belgium). The QC laboratories are operating from the existing J&J Beerse site. CAR‑T investigational medicinal and commercial CAR‑T products are manufactured in the Ghent facilities. In this role, you are reporting in the J&J QA CAR‑T organization and work closely with your peers from Material Science and Technology, Operations and Quality Control. The Qualified Person, CAR‑T Europe is responsible that product and process related investigations, complaints, batch review and release activities are accurately handled on time and in line with all ATMP/GMP requirements. About Your Skills and Experience
Qualifications/Requirements: A degree in Pharmacy or Bio‑engineering is required. Certification as an Industrial Pharmacist is required (Qualified Person number). In‑depth understanding of pharmaceutical product development, qualification, packaging, validation, testing, release, and distribution processes. Regulatory Knowledge: Up‑to‑date knowledge of pharmaceutical legislation, including current Good Manufacturing Practices (cGMP) and Advanced Therapy Medicinal Products (AT) regulations. Strong analytical thinking and decision‑making abilities, with a keen attention to detail. Excellent verbal and written communication skills to optimally negotiate and interact with both external and internal customers and partnersli> Proven experience working with quality systems, ensuring compliance with industry standards and regulatory requirements. Experience with aseptic processing and techniques is preferred, with a solid understanding of the requirements for sterile manufacturing. Highly organized, capable of managing multiple tasks in a team environment, and able to work optimally under minimal direction while maintaining a positive demeanour. Effective Communication: Strong written and verbal communication skills in English is required. (Dutch is a plus) Where Molecules Meet Opportunities
Hybrid Work You are eligible to work in EU
We only accept applicants who are eligible to work in the EU At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com
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Apply now About the vacancy
R&D Drug Development Quality Quality Control Quality Assurance Compliance Regulatory Affairs Regulatory Affairs Regulatory compliance Submissions Clinical R&D Pharmacovigilance Engineering Quality Expert Bachelor’s Degree (HBO, WO) Permanent Full time Ghent, Gent, Belgium About Your Next Job
We are looking for the best talent for a Qualified Person – Quality Assurance for the CAR‑T hub to be in Ghent Belgium! Purpose:
CAR‑T (chimeric antigen receptor T‑cell therapy) is an innovative approach to eliminate cancer cells, which work by harnessing the power of a patient’s own immune system. They are created from the patients’ own T cells and are engineered to eliminate cancer cells expressing a specific antigen. To support the CAR‑T program in EMEA, J&J has built two CAR‑T manufacturing centers in the Ghent area (Belgium). The QC laboratories are operating from the existing J&J Beerse site. CAR‑T investigational medicinal and commercial CAR‑T products are manufactured in the Ghent facilities. In this role, you are reporting in the J&J QA CAR‑T organization and work closely with your peers from Material Science and Technology, Operations and Quality Control. The Qualified Person, CAR‑T Europe is responsible that product and process related investigations, complaints, batch review and release activities are accurately handled on time and in line with all ATMP/GMP requirements. About Your Skills and Experience
Qualifications/Requirements: A degree in Pharmacy or Bio‑engineering is required. Certification as an Industrial Pharmacist is required (Qualified Person number). In‑depth understanding of pharmaceutical product development, qualification, packaging, validation, testing, release, and distribution processes. Regulatory Knowledge: Up‑to‑date knowledge of pharmaceutical legislation, including current Good Manufacturing Practices (cGMP) and Advanced Therapy Medicinal Products (AT) regulations. Strong analytical thinking and decision‑making abilities, with a keen attention to detail. Excellent verbal and written communication skills to optimally negotiate and interact with both external and internal customers and partnersli> Proven experience working with quality systems, ensuring compliance with industry standards and regulatory requirements. Experience with aseptic processing and techniques is preferred, with a solid understanding of the requirements for sterile manufacturing. Highly organized, capable of managing multiple tasks in a team environment, and able to work optimally under minimal direction while maintaining a positive demeanour. Effective Communication: Strong written and verbal communication skills in English is required. (Dutch is a plus) Where Molecules Meet Opportunities
Hybrid Work You are eligible to work in EU
We only accept applicants who are eligible to work in the EU At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com
#J-18808-Ljbffr