Senior QA Specialist

Are you looking for a workplace where wellbeing, professionalism, and growth go hand in hand - and where you can truly develop both personally and professionally?

For our client, Unilabs A/S, we are seeking a skilled and dedicated Senior QA Specialist to join their team in modern office and laboratory facilities in Østerbro.

At Unilabs, you’ll become part of a highly competent and collaborative team, where strong professional expertise is combined with a genuine commitment to quality. The culture is defined by a supportive and social work environment, where achievements are recognized and celebrated together

The Senior QA Specialist´s main purpose is to ensure that the company always works in compliance with the quality management system selected by the management and that this system is kept updated according to the different standards. 

The key responsibilities include:

• Ensuring that the work is carried out in accordance with Unilabs' quality assurance system and applicable rules within GCP, GCLP, CLIA and ISO 15189 (IVDR).

Specific Duties:

• Audits:
  • Preparation and Conduction internal audits (facility, process, study-based) 
  • Conducting internal audits (facility, process, study-based).
  • Conducting external audits and approval of Center of Excellences (CoE).
  • Conducting supplier audits.
  • Hosting authority inspections and customer audits.
  • Facilitate and represent Unilabs Pharma solutions during customer audits at CoE sites.
• Providing quality training.
• Administration and maintenance of the Quality Management System.
• Deviation management, including root cause analysis and Corrective and Preventive Actions (CAPA).
• Handling and reporting various Key Performance Indicators (KPIs) to Management and Group QA.
• Participating in relevant meetings, committee tasks, and training.
• Supporting the organization in quality-related projects and improvements.
• Review and input to  Master Service Agreements.
• Acting as the QA responsible in authority registers.
• Preparation of the Quality Management review.

Reporting Relationships:

• The role reports to the Head of Quality Assurance, Unilabs Pharma Solutions at York and the Site Manager of Unilabs CPH.
• The role can be substituted by employees of the QA team at Unilabs Pharma Solutions, CPH.
• Closest business partners: The QA and regulatory group, Scientist, Lab Technicians, Project Management, CoE, Customer Service and the commercial team.

Qualifications and experience:

•    Educated as a Bio analyst, Lab Technician or holds a B.Sc. or M.Sc. in a relevant field

•    5 years of experience in a similar position
•    Theoretical and/or practical experience with GCP, GCLP, ISO 15189, IVDR or similar
•    It's an advantage if you hold a Lead Auditor certificate - but it's not a requirement
•    Good communication skills with many customer contacts                                        

•    Fluency in English is required (both written and spoken)           
•    Basis Danish is a requirement  

Benefits: 

• International, collaborative, and regulated product environment 
• Competitive compensation and benefits 

• Long-term ownership of a strategic healthcare product

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