Beschrijving vacature

The Computerized System Validation Technical Expert will assure that Computerized Systems Development Documents meet regulatory and Hovione compliance requirements throughout their life cycle. It will also participate in Projects among different areas, promoting a continuous improvement quality culture focused on patient safety, customer satisfaction and compliant with the applicable regulations.

Main responsibilities:

  • Definition of required Qualification and Validation strategies for different Computerized Systems: Analytical Equipment,

    Manufacturing Equipment, DCS, PLC and Software;
  • Review and approve Computerized System Development Life Cycle documentation, incident investigations and change

    controls related to Computerized Systems;
  • Participate in Engineering, or other Projects seeking for the best technical solution and cGMP compliance;
  • Guarantee a risk based approach for the Qualification & Validation activities;
  • Keep area up to date with guidelines on Computerized System Development Life Cycle and related technologies/tools.

Profile:

  • Academic degree in Engineering field such as Mechanical, Electrical or Chemical or equivalent degree in a scientific area;
  • At most 5 years of experience in Chemical / Pharmaceutical Industry environment;
  • Experience on computerized systems validation practices and regulatory requirements, including GAMP 5, Eudralex Annex 11 and 21 CFR part 11, will be a differentiation;
  • Knowledge of Data Integrity principles and Risk Management tools, preferential but not mandatory;
  • Analytical skills, proactive and creative personality;
  • Ability to multi-task, work independently, be self-directed and organized;
  • Comfortable working in a fast-paced and dynamic work environment;
  • Team working and multi-disciplinary approach ability;
  • Good communication skills;
  • Accuracy and responsibility;
  • Good English level (written and oral).     

We offer:

  • Full time opportunity;
  • Remuneration and social benefits adjusted to the job function and matching the experience;
  • Excellent work environment, with a strong focus on quality. 
Functiebeschrijving
Sector:
Manufacture of basic pharmaceutical products and pharmaceutical preparations
Beroepsveld:
Engineering professionals (excluding electrotechnology)
Onderwijsveld:
Engineering and engineering trades
Werkervaring:
Work experience is required
Duur van de werkervaring:
More than 5 years
Taalvaardigheden:
  • English
  • Good
Salaris van/tot:
Not provided
Date of expiry:
Loading...