Job details

GMP & Regulatory Compliance Expert - Industrial Pharmacist

Company details

Air Consult Engineering SA provides Integrated Engineering Services and GMP/Validation Consulting Services in the pharmaceutical and biotechnology industries, and in hospitals: aseptic production areas, hospital pharmacy, controlled environments or critical and ultra-pure utilities, and specialized laboratories with high level of constraints: clean rooms, biological or radioactivity containment, climatic chambers, animal facilities, disinfection systems, production equipment...

As an independent Office, Air Consult Engineering takes full responsibility for the project cycle: from project definition up to detailed commissioning and validation, and this both for modifications of existing facilities as for the construction of new integrated units.

Air Consult Engineering claims the decisive contribution of a horizontal approach in the draft process with a structured listening to end-user requirements in all their dimensions.

Recognized by the biggest names in the pharmaceutical industry, Air Consult Engineering currently employs over 30 people and has grown steadily from 20% a year since 2005.

To meet the demand of its customers, Air Consult Engineering wishes to appoint a GMP & REGULATORY COMPLIANCE EXPERT – INDUSTRIAL PHARMACIST (m/f).

Function

Your challenge as an Expert at Air Consult Engineering:

At the head of an Expertise team, you ensure rigorous compliance with end-users requirements, including regulatory requirements, in project designs at Air Consult Engineering.

  • You are responsible for a national and international regulatory monitoring in the sectors in which Air Consult Engineering develops
  • As part of the project definitions, you make an exhaustive list of user requirements and you translate those requirements into technical solutions with the help of your team
  • You make sure that regulatory changes are reflected in the project definitions and in the programming conducted by the Office
  • You make sure that the project Quality Assurance procedures specific to each business areas involved are applied at Air Consult Engineering
  • You advise the clients on the implementation of the required systems for obtaining the necessary accreditation regarding their projects, and you potentially assess the gaps and training.
  • You establish a long-term relationship of trust with customers and regulatory authorities.
  • As recognized player in the trade, you are participating actively in the influence of Air Consult Engineering for clients and in the business.

Profile

Your Assets: A Passion for Defining User Requirements and Translation in Technical Language.

  • You are an Industrial Pharmacist
  • You have at least 10 years of multidisciplinary experience in different departments within the pharmaceutical industry or equivalent: Production departments, QA, Validation, Engineering, Projects,...
  • You are trained in cross-disciplinary approaches to problem solving
  • You have a good knowledge of the processes and technical applications of the sectors in which the company operates.
  • You master the process analysis and risk analysis tools.
  • You are fluent in French, English and the knowledge of Dutch is an asset.
  • You are precise, organized, rigorous, and your priority is to listen carefully to customer needs and to translate them in terms of process and regulatory compliance
  • Combining field approach with strategic vision, you communicate with ease in order to lead a project team and catalyze energies.
  • You are autonomous, analytical, problem-solver and visionary, and you are full of initiative.

Tags: pharmacien d’Industrie, pharmaceutical, industrial pharmacist, regulatory, GMP, project management, Assurance Qualité, Quality Assurance, Validation, engineering, farmaceutisch, farmaceutica, validatie, biotechnologie, ingéniérie, engineer, life sciences, pharmaceutique, hôpital, commissioning, biotechnology, hospital, pharmaceuticals, engineering, pharmaceutical, industrie apotheker

Offer

Our offer: With your expertise, you contribute to the development of a growing SBE.

  • We offer you a rewarding opportunity to benefit clients and the internal organization of Air Consult Engineering from your expertise and experience by supporting an integrated and transversal approach from the project definition to the final required documentation.
  • You have the means and autonomy to define and develop new skills or new offerings and thus contribute to the company's growth.
  • The opportunity to build your career in an SME evolving in leading sectors.
  • A varied work with different projects, the challenge and the passion of an SME that applies its values ​​of trust, respect and commitment on a daily basis.
  • A company that enhances its value through constant trainings and through the prospects it offers to its employees
  • A full attractive salary package related to your level of responsibility.

  • Location: Gosselies

AIR CONSULT ENGINEERING Sa

Aéropole I-Tech Incubator - Rue Auguste Piccard 48
6041 Gosselies
Belgium

  • Tel: 071/25.40.30
E-mail

Interested?

For more information:
Call VANESSA SIDDU
at the number: 071/25.40.30
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