Quality Person In Plant - #54781

Functiebeschrijving

The Quality person in plant is an exempt level position with responsibilities for providing quality oversight over the production of a personalized cell therapy to support both clinical and commercial requirements in a sterile GMP environment. Job duties are performed within a team according to an assigned, production shift schedule. This role will work in shift regimes supporting the 7/7 days cell processing.

Major Responsibilities

• Serves as a Quality person in plant in support of cell therapy manufacturing.
• Ensures Quality Oversight in plant covering various process related activities
• Performs periodic Quality checks/audits related to process, documentation and process manipulations
• Strive to reduce non-conformances and deviations in supported areas by proactively driving compliance.
• Responsible for real time review of process documentation in support of process unit operations and release activities where needed.
• Collaborate with site personnel to provide guidance and determine resolution for manufacturing issues.
• Supports in accurate and timely input, investigation and review of manufacturing deviations, CAPAs, change controls and complaints.
• Review and approve manufacturing procedures and batch records
• Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
• Support regulatory inspections and audits by ensuring inspection readiness within facility.
• Perform internal housekeeping audits.
• Other duties will be assigned, as necessary.
  
  

Wie ben jij?

• Education:
  
  

A minimum of a Bachelor’s Degree in Science, Engineering or equivalent technical discipline is required or relevant years of experience within the pharmaceutical industry.

• Experience:
  
  

A minimum of 2 years relevant work experience is required. It is preferable that the candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy. A minimum of 2 years of experience with quality support in clinical manufacture is preferred.

We offer extensive, in-house training after which you can start working smoothly in your new role.

• Languages: You are proficient in Dutch and/or English, with strong written and oral communication skills.
  
  

Wat bieden wij jou?

What do we offer?

A meaningful job, close to your home, with a very nice work-life balance. You work 4 days, then you have 4 days off.

At Legend Biotech, you find more than a career. We offer you a path to growth, learning and personal development in an innovative environment, surrounded by colleagues you can really count on.

Enjoy the opportunity to work with people from all over the globe. We are fully committed to diversity and inclusion and value every voice.

The opportunity to volunteer for numerous projects and charities, allowing you to develop new skills.

An indefinite contract and an attractive salary complemented by a comprehensive package of fringe benefits such as additional legal vacation days, meal vouchers, group and hospitalization insurance. And as icing on the cake, you'll also receive annually double vacation pay, an end of year bonus and a performance bonus.

A lot of fun and informal events.

Extralegale voordelen

Maaltijdcheques Laptop Hospitalisatieverzekering Groepsverzekering

Competenties

Gedisciplineerd Nauwkeurig Teamplayer