Senior QA Specialist GMP
KLIFO is looking for a Senior QA Specialist GMP for our Glostrup office
Would you like to use your solid GMP QA experience as Senior QA Specialist to support our internal manufacturing department, as well as our increasing number of external customers from international biotech and pharma in a variety of quality tasks?
At KLIFO we are working with drug development projects broadly and with supply to clinical trials. Through our customers we guarantee exciting challenges within different kinds of pharmaceutical development and manufacturing. Tasks are related to both Drug Substance and Drug Products, including plain tablets, aseptic manufacture, manufacture of biologics and Advanced Therapy Medicinal Products (ATMP), import of Drug Products from third countries and different QP to QP responsibilities.
Due to a growing QA business we’re looking for a new colleague to become part of our experienced Quality Assurance Team reporting to Anne Ploug Jørgensen, Senior Director Quality Assurance.
The position:
As Senior QA Specialist at KLIFO you will be working with a diversity of jobs from traditional QA tasks for our local packaging production, writing of SOPs to QA counselling of small biotech companies. Sometimes we get the chance to work from a client site, that can be up to a few days a week. External audits will also be part of the job and you must therefore expect some traveling.
Qualifications:
Preferably you are a pharmacist or have through a different path gained competences to qualify as a QP/QP Delegate. You have some experience in pharmaceutical manufacture including aseptic preparation and know about biological products. Knowledge about ATMP will be an advantage.
You must have solid experience with QA work and QMS design and maintenance, be open to contribute to preparation and review of SOPs, review and release batch documentation, support and approve validation, perform audits and handle quality incidents and CAPAs.
We offer:
As our new Senior QA Specialist GMP you will:
- Work with a diverse client pool (pharmaceutical companies, established biotech, inexperienced, virtual biotech, investigators/ academia)
- Get the opportunity to bring all your pharmaceutical competences into play in a position with many different QA tasks
- Join an open, flexible and positive working environment with a high degree of influence and transparency
- Collaborate with a team of dedicated and experienced colleagues
Location:
KLIFO has offices in both Denmark, Germany, Sweden and the Netherlands. This position is located at our office in Glostrup, Denmark.
Contact:
For more information, please contact Anne Ploug Jørgensen, Senior Director QA, +45 44 222 982.
Applications should be sent to:
moc.ofilk@boj marked Senior QA Specialist GMP.
KLIFO processes your application and all related personal data exclusively for the specific hiring process. Your data is processed as confidential information, cf. the current data protection law (GDPR).
Deadline:
Please apply as soon as possible. Recruitment interviews will be held on an ongoing basis