Site Compliance Network Member

Function

This position is part of the Site Compliance Network Member (SCNM) team, which is the independent product-oriented quality team that has certain responsibilities concerning registration, validation and implementation within the site. Each SCNM is assigned one or more specific product(s) for which he/she is responsible.

Registration

The production processes and analytical methods of the drug products are described in the registration dossiers of the different markets. The SCNM is responsible to ensure regulatory CMC compliance of the practice of the site versus the content of the registration dossiers. This is achieved by participating in the following processes:

  • Renewals: maintain and support the existing registrations in the markets
  • Regulatory change control process:
  • Determine regulatory impact for proposed process changes
  • Compile the required supporting data package for the regulatory submission (variation)
  • Respond to Board of Health queries
  • Respond to compliance-related questions from Boards of Health
  • Performing regular compliance checks of the registration dossiers of the different markets versus the site practice to ensure that the site practice is still in line with the dossiers

To this end, the SCNM has intensive consultations with partners within and outside the site. The external contacts with the Boards of Health of the markets mainly go through their GCMC (Global Chemistry, Manufacturing & Controls), with whom the SCNM maintains a close partnership. An important role of the SCNM is to form the bridge between the site and GCMC (~Boards of Health); on one hand the SCNM informs site colleagues on regulatory requirements, timelines, etc. and on the other hand the SCNM guards the interests of the site in external discussions.


Validation

The SCNM is the independent quality authority for product-related validations and in that way guards the quality of those validations and therefore the product quality. The validation domains in scope are:

  • Process validation
  • Method validation
  • Filter validation
  • Component qualification
  • Raw material evaluation


Implementation

The SCNM assist in coordinating the implementation of changes with regulatory impact in the site. To this end, he/she will follow up on the submissions and approvals in the different markets, and will provide this feedback to the site colleagues.

In addition, the SCNM is responsible for the content of the test plans (master data) in the LIMS system. This way, the SCNM ensures that the testing performed on the drug products is in compliance with the registration dossiers of the different markets.


Profile

  • Degree: University
  • Formal education: Scientific discipline (e.g. industrial pharmacist, biomedical sciences, bio-engineer,…)
  • Experience required: Minimum 2 years experience in the pharmaceutical sector (or equivalent by acquiring a PhD), with experience or interest in documentation of manufacturing methods or test methods

Specific training and skills:

  • Excellent oral and written communication
  • Excellent social skills
  • Scientific knowledge and skills
  • Fluent in English and Dutch

Offer

  • Een competitief salaris aangevuld met een brede waaier van extralegale voordelen (afhankelijk van contracttype en voorkeur).
  • Tewerkstelling bij een stabiele en gevestigde speler (meer dan 20 jaar) in de consultancywereld.
  • Een werkomgeving waar de focus ligt op eenieders sterke eigenschappen en de verdere verbetering daarvan.
  • Details

    Pharmaceutical
    Project Engineer Pharma

    Klein-Brabant
    2017-01-03
    Vast / Tijdelijk

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