Due to increasing activities the QA Operations team is looking for an EU Qualified Person with experience in the disposition of aseptically manufactured biological products and knowledge of sterile manufacturing processes to assist with batch release of biological API for phase I-III clinical trials and commercial manufacturing

About the Role
As delegated Qualified Person (QP) responsible for the certification of drug substance and active biological Finished Goods within the European Union (EU) of medicinal products for human use holding a Marketing Authorization (MA) or made for export as per European Directive 2001/83/EC, 2017/1572 as well as well as delegated regulation 2017/1569. Responsible for batch certification of commercial and clinical finished product for the EU and Rest of the World following respectively Annex 16 and 13 of EU regulation.

About QA Operations
QA Operations consists of highly qualified scientists with various professional backgrounds and several years of experience within Quality Assurance. Besides the QA Operations team, the quality unit department consist of the teams Quality Systems and QA Facility and Equipment. The main responsibility of the QA Operations team is quality assurance of QC documentation, manufacturing activities and batch release.

We are actively involved in the constant development within our field and the continuous improvement of our quality system. We aim at constantly ensuring that QC and manufacturing are in compliance with current standards for GMP production, i.e. EU GMP, 21 CFR and ICH guidelines.

The department has an open communication with focus on a high level of professionalism. We are open-minded and have a high support level to our colleagues in the rest of AGC Biologics A/S - and not least to our international customers. The QA Operations team is characterized by positive and proactive colleagues meeting deadlines through committed and friendly collaboration.

You will join the QP team of like minded individuals passionate about product quality and patient safety. You key role will be the release of mammalian, microbial and clinical trial supply asd well as commercial products. However, as described in Annex 16 of Eudralex Volume 4, you will be involved in the “routine duties” of the Qualified Person. 

Responsibilities            

  • Responsible for batch disposition
  • GMP SME
  • Regulatory / Compliance support
  • Support senior QA leadership through QP decision making to drive continuous improvement and ‘fitness for purpose’.
  • Manufacturing Shopfloor presence
  • Actively develop, mentor, train and enforce a site GMP culture within Operations
  • Support for regulatory inspections
Candidate Profile
MSc in Industrial Pharmaceutical Science or similar course recognized by Regulatory Authority to permit Qualified Person (QP) status as per Article 49 of Directive 2001/83/EC with typically 7 to 10 years’ experience in the healthcare/pharmaceutical industry gained in an FDA / EMA regulated and approved pharmaceutical environment.
 
Your experience should be:
Experience as a Delegate / QP from biotech or pharmaceutical industry essential. Well developed communication skills; Coaching / mentoring; Expertise in one or more Pharmaceutical Operational areas e.g. QA, QC, Manufacturing. Strong working knowledge of the principles and guidelines for GMP. 
 
Your  personal competences should be: 
Attention to detail, critical thinking, analytical and problem-solving skills. Strong decision making skills and ‘can do’ attitude. Ability to work in a fast paced, matrix environment essential. Capable of working to deadlines and prioritize multiple tasks. Flexibility to meet changing needs and priorities of the business. Strong ability to work independently.
 
Join an international and agile organization
At AGC, you will get great opportunities to work with a wide array of tasks and challenges, and you will get experience with our various departments. Furthermore, as we plan projects and tasks together in the team, you will get the opportunity to influence your daily work. AGC offers an informal working environment where high energy and enthusiasm is part of the daily work life. We respect each other and our individual differences. At AGC, we have a flexible attitude and we help each other reach deadlines as a team.
 
Contact and application
For any further questions, your are more than welcome to contact Ayo Ogunsanlu at aogunsanlu@agcbio.com or phone: +4526894978

Please be aware that we take in consideration only the applications send via our career page and, not via email. We will process the applications as they arrive.
 
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AGC Biologics (AGC) is a global Contract Development Manufacturing Organization (CDMO) with bio-manufacturing facilities in Europe, Japan, Italy and the USA. The company provides a comprehensive range of commercial and clinical cGMP biologics manufacturing services, from DNA to active pharmaceutical ingredient (API). The company’s team and approach are tailored to each of its client’s needs, whether turnkey manufacturing or sophisticated, stand-alone analytical, formulation and stability services.

Visit www.agcbio.com to learn why AGC Biologics is a World Leader in process development and contract manufacturing.

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