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Your responsibilities in the role
AGC Biologics CPH continues to enjoy great success, and we are expanding with a new state of the art multipurpose production facility in CPH to be in use from Q3 2023. With this new production facility and a steadily increasing number of computerized validation/qualification activities – we are going to need strong skilled IT minded validation/qualification experts with expertise for driving validation activities end-2-end for computerized software.
Key responsibilities:
- Responsible for performing computerized qualification test and protocols, compiling data and completing validation reports for implementation of new software.
- Oversight the different validation activities from planning, execution to completion
- Updating and optimizing current procedures when needed, such as PART 11 Data integrity activities
- Report on progress and milestones to stakeholders
The position offers interaction with different stakeholders both from the site in CPH but also from talented colleagues around the global AGC network. You will be introduced to global biopharmaceutical companies and be an active player in their projects.
The department that will be looking forward to have you on board
You will be a part of the newly formed Facility & Equipment validation department, where currently 14 highly qualified team members are waiting for you. We share a fun/relaxed tone while at the same time have high ambitions to deliver best in class validation/qualification activities across the entire organization, to benefit our global biopharmaceutical costumers.
Why we would will like to have you as part of the team
In our new colleague, we are looking for a person with:
- A relevant academic background and at least 5 years of relevant experience with GMP/IT/validation.
- You have experience or interest within pharmaceutical Quality Management, or you have taken part of GxP system validation and wish to grow in
- Experience with PART 11, GAMP 5, Data integrity from a GxP environment, would be seen as a plus.
- Make things happen in a context of high complexity
- Excellent English language skills both verbally and written
- Good team player, open minded and result-orientated.
- Ability to effectively communicate with a broad audience of stakeholders
We will process the applications in the order they arrive. Therefore, please submit your application and CV as soon as possible, When the right candidates are found, the add will close. For any further questions, are you welcome to contact Jeppe Palm Beckmann on [email protected] Please be aware that we only take applications into consideration that are send via our career page.
AGC Biologics
AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics. We forge exceptionally strong partnerships with our clients, and we never lose sight of our promise to deliver a reliable and compliant drug substance supply.
AGC Biologics offers a dynamic working place and an excellent opportunity for working and growing with a varied array of tasks and challenges. You will get insight into and experience with the way the various departments throughout the company interact in order to achieve success. Exciting and challenging assignments will keep coming your way, but you will to a large extent be able to plan your daily work on your own. AGC Biologics offers an informal working environment, where humor is part of the daily work life. We respect each other and our individual differences. AGC employees have a flexible attitude and we help each other to reach deadlines together as one team, in accordance with our slogan - Right. On Time.
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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.
Information og data
Denne ledige stilling har jobtypen "Forsker", og befinder sig i kategorien "Sundhed og forskning".
Arbejdsstedet er beliggende i København
Jobbet er oprettet på vores service den 16.10.2022, men kan have været deaktiveret og genaktiveret igen.
- Forsker
- København
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