Job ID: 12437

Qualified Person (m/f/d)

For a top pharmaceutical company (CDMO) in Bavaria, we are looking for an experienced and highly qualified person with expertise. Here you can work in an exciting environment and make a significant contribution to drug safety. If you would like to become part of this team, we look forward to receiving your application.

Job Type.

Permanent

Your tasks.

  • Performing the tasks of a Qualified Person in accordance with § 14 AMG and Annex 16 of the EU GMP guidelines.
  • Keeping a continuous register of all released batches in accordance with § 19 AMG in conjunction with § 17 AMWHV.
  • Compliance with and monitoring of applicable pharmaceutical legislation, e.g. AMG, GMP, AMWHV, BtMG.
  • Evaluation and approval of product and/or batch-related documents required under pharmaceutical law, e.g. PQR, APR.
  • Processing and evaluation of deviations and test reports.
  • Monitoring of GMP and authorization/registration-compliant manufacturing and testing of medicinal products in accordance with AMG, AMHWV and the EU GMP guidelines.

Your requirement profile.

  • Completed degree in pharmacy or license to practice as a pharmacist (f/m/d) and several years of professional experience in a GMP-regulated environment.
  • Expertise in accordance with §15 AMG and recognition as a Qualified Person (QP) by a state authority in Germany in accordance with §14, §15 and §19 AMG.
  • Experience in quality assurance and ideally audit experience.
  • Strong teamwork skills, ability to work under pressure, ability to work independently and very good communication skills.
  • Very good knowledge of German and English.

Pros.

Not specified

Salary.

From: Not specified
Until: Not specified

Region. Category. Discipline.

Application. Advantages.

Not found a suitable job?

FAQ. Applicants.

Apply anyway! We will then decide together whether it is worth applying. If not, we will look for another job together that fits your needs and qualifications.

For the most part, they are. However, there are also jobs that are not yet online. So if you don't find a job that suits you, it's still worth sending us a speculative application or simply giving us a call.

Of course we do! Even if no suitable position is advertised online, we may still have a suitable position for you.
Send us an unsolicited application or give us a call: together we will discuss everything else.

Project Consultants are permanent employees of Entourage who work for clients on temporary projects. As soon as the project is finished, there is either the possibility that the customer takes over the Project Consultant in a permanent position or the Consultant continues to work for Entourage in a new project.

It's always worth contacting us. Even if you're not looking for a new job yet. Together we can explore possibilities and opportunities and determine your current market value.

No, that is not necessary! It is sufficient if you apply for one of the positions and indicate in your message that there are other positions you are interested in. Our employee will then take care of everything else.

You should always keep us in the picture as to whether you have applied for jobs independently or through another recruitment agency.

After you have sent us your complete application, the responsible employee will look through your documents and then get in touch with you. Either by e-mail or by phone.
In the first phone call, you will talk about your wishes and goals and make an initial assessment of whether and which jobs from our range are suitable for you.
In a further conversation, the sales consultant responsible for the company will talk to you and check whether you are suitable for the position. In this way, we can guarantee with a high degree of probability that you will sign the contract at the end of the application process.
After that, it's straight into the application phase. We forward all the necessary information to the company and keep you informed about interview dates.
Once an interview date has been set, we will prepare you for the upcoming interview in the best possible way.

The easiest way to apply is via our application form. Either directly to the position you want or as a speculative application.
This way, the consultant in charge knows directly which position you are applying for and can look at your documents before contacting you.
As soon as your CV and other documents such as references and certificates are available, our consultants can start working and find a suitable position for you.

The most important thing for us is an up-to-date CV. In addition, your name, telephone number and/or email address are important so that we can reach you.
Other documents such as certificates, references, cover letters and the like can also be submitted later if necessary. However, it does not hurt to include all relevant information directly in the application.

Data protection is very important to us. Precisely because we deal with people and sensitive, personal data on a daily basis, we pay very close attention to what information we pass on to third parties. 

Before we pass on a person's data, we always clarify whether the person agrees to this. 

We store our customers' data on secure servers within Germany.