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Batch Record Reviewer - Belgium  

Keyrus Biopharma (company)


Posted on : 01 May 2017

Project Description

Job Description
We are looking for a Bilingual NL/FR Batch Record Reviewer for one of our clients.

Role and main tasks (NL and Eng version)
  • Current environment is very busy and we are looking for someone to step in quickly to help
  • There is significant back-log to get rid of, so person needs to like working under pressure but with lots of recognition and support
  • Training will be given, after which the person is expected to be far more autonomous and independent
  • Evaluating and approving batch records is key (bulk products, bottling and packing)
  • Initiate additional controls to those in place (QP) if necessary
  • Review and approve certificates, incl. inspections
  • Reviews of anomalies
  • Execute tasks required  

Bachelor degree ideally or equivalent experience 

Required skills: 
  • Experience in batch reviews in an industrial setting
  • Knowledge of safety, production and GMP operational environments is a plus
  • Must have excellent knowledge (spoken, and read) of Dutch/Flemish
  • French is needed too
  • Strong sense of urgency
  • Willing to take responsibility
  • Independent and autonomous
  • Willing to ask questions and a quick learner
  • Strong communication skills in NL
  • NO shift work is needed  

What we offer
  • You will receive a competitive based salary depending on your education and experience in an attractive package of extralegal benefits (company car, petrol card, meal vouchers, group insurance, hospitalization…). 
  • Each employee will be welcomed with a varied integration program. 
  • We invest considerable time and resources in training our staff (technical and non-technical courses). 
  • You will join a dynamic and international environment with enthusiastic and professional colleagues. 

Who We are
  • Our company is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence. 
  • Our ‘human’ approach to service provision is what differentiates us from our competitors.
  • Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research. 
  • We’re proud of our commitment to delivering services of the highest quality, not only skillfully, efficiently and reliably, but also with sincerity and genuine care for our clients’ projects, priorities and reputation. Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better 
  • From early- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Bio statistics, Medical Writing & Medical Information, Real World evidence services.