KLIFO A/S is looking for a talented and committed person to strengthen our QA department.
KLIFO is a growing company operating in the international life sciences market. We are a service provider of drug development competences and operational services to pharmaceutical, biotech and med-tech companies in Europe, US and Asia. Our services include Drug Development Counselling, Clinical Trial Supply, Clinical Trial Services, Regulatory Affairs and Pharmacovigilance.
QA Manager and QP Delegate
As QA Manager in KLIFO A/S you will have the responsibility of administrating KLIFO´s Quality System and participating in QP tasks as QP delegate. In this new position, you will be a part of a dynamic team and handle various QA and QP tasks in collaboration with KLIFO´s Clinical Trial Supply function.
Your responsibilities will include:
• Overall administration of our SOP system
• Administration of deviation, complaints, change control and CAPA system
• Responsible for QA monitoring
• Approve batch documentation
• Release IMP for clinical trials
• QP participation in costume related projects
• Preparing and reviewing of Quality Agreements
• Preparation and participation in annual Quality Management Review
• Ongoing updates to Validation Master Plan
• Participation in GMP training of employees in Clinical Trial Supply
• Participation in self-inspections and audits
An ideal candidate is a person committed to creating and delivering solutions that meet individual customer needs.
The candidate should be engaged and have the capacity and drive to develop the job and the QA function further.
Also, the person must have a positive, proactive, flexible and self-aware personality.
Education, experiences, knowledge and skill:
The QA Manager must have relevant competencies and experiences:
• Pharmacist or equivalent, with competencies and experiences from a similar position in the pharmaceutical industry, preferably within pharmaceutical development
• Solid knowledge of GMP and GDP, GCP is preferable
• Ability to work in a flexible and changing environment
• Good communication skills (written and oral), in both Danish and English
• Team oriented personality with a high degree of flexibility
• Ability to prioritise different tasks to meet strict timelines
• Carrier opportunities
• An inspiring working environment in a growing company
• High job variation
• International and external relations
• High level of influence
KLIFO is located at Smedeland 36, 2600 Glostrup.
For more information, please contact Lars Bo Nielsen, Director, Quality Assurance and QP on +45 44 222 980.
Applications should be sent to:
28. October, 2016
For more information on KLIFO, please visit: www.klifo.com