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Compliance & project manager

Via Pauwels Consulting

Pauwels Consulting is a Belgian consulting firm with more than 490 experts in engineering, life sciences and IT. We offer consulting, project management and recruitment services to leading companies in Belgium and beyond. We have offices in Belgium, France, Germany and Switzerland (https://www.pauwelsconsulting.com/about/contact/) .

Compliance & project manager

Job description

Being back-up of the pilot plant scientist. Coordinates, plans, tracks and monitors all pilot plant activities especially with regard to equipment and premises in alignment with Head of pilot plant. Ensures good collaboration with all customers and stakeholders of the pilot plant and warehouse and provides active scientific and technical guidance/support them. Develops and maintains fit-for purpose equipment and premises that are compliant with all relevant regulatory guidelines (e.g. cGMP and HSE) and SOP’s. Provides and defines efficient workflows and business processes especially with regard to equipment and premises in alignment with Pilot Plant Manager.

  • To support all customers (e.g. Formulation and Process Development Group, Characterization and QBD group) and stakeholders (e.g. QA, metrology, qualification, maintenance, and site facilities) with technical assistance and coordination of technical activities
  • To support the development and maintenance of an overall process in order to ensure that all premises and equipment are in an appropriate condition ready for pharmaceutical use
  • To train co-workers in the field of quality/safety related technical operations
  • To ensure cGMP compliance of premises, equipment and procedures within the pilot plant and warehouse area as determined by the manager
  • To ensure that quality assurance activities are carried out in time
  • To support the planning, preparation and performance or initiation of equipment related qualification/validation activities
  • To provide appropriate documentation of all quality related activities
  • To apply all relevant regulations, guidelines and operating procedures (regulatory, quality and safety)
  • To perform periodical evaluation of equipment and premises
  • To support audit preparation and audit follow-up
  •  To manage and support all administrational affairs to smoothly operate in pilot plant and warehouse area and/or internal and external interfaces as determined by supervisor

Profile

  • Min 5-7 years experience in a laboratory or manufacturing environment, preferably in pharmaceutical or chemical industry
  • Experience in a GMP regulated environment
  • Experience in both R&D and commercial manufacturing of the pharmaceutical industry is an asset
  • Working with Trackwise, Source, SAP is a huge asset.
  • Very good administrative, organizational and documentation skills are mandatory
  • Ability to work according to given instructions and to handle chemicals
  • Good knowledge in English is mandatory

Offer

  • Challenging projects based on your interests and skills 
  • Personal follow-up and clear, transparent communication both before and after commencement of employment
  • Possibility to follow extra training
  • Inspiring network events and legendary after work drinks
  • Strong network of industry leading clients
  • Expertise within IT, Engineering and Life Sciences
  • A flying start for every junior, growth opportunities and possibility to share gathered knowledge for more senior employees
This job is no longer available.

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Characteristics

Requirements

  • Master (University or Higher Education Long Type)

Offer

  • Permanent
  • Independent
  • Full-time

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