Regulatory Compliance expert / Industry pharmacist

25-10-2020 mons
company profile

Our client, a design office which wants to be the pole of business & technical expertise which, based on the solid experience of its collaborators and an agile structure, proposes "tailor-made" project approaches, more integrated and pragmatic. 

job description

We are looking for the candidate who will make the difference for the position of Regulatory Compliance Expert / Industry pharmacist.

If this position matches your profile, then please send me your application without delay to the following address, olga.silitti@cx.ausy.be.


As an expert in national and international legal regulations, you anticipate and follow the evolution of the regulations, especially in pharma industries. You ensure and coordinate the project definition, i.e; the interpretation. You are also responsible of the coordination & validation strategy.

OPERATIONAL RESPONSIBILITIES

Ø  REGULATORY AND LEGAL WATCH

• Assess the clients needs and define the functionalities requested or needed

• Proceed to a national and international regulatory and scientific watch

• Assess the impact of the regulatory evolutions

• Share the regulatory and scientific information with the appropriate department

• Manage the regulatory documentation archives

• Search and use the regulatory data bases 

Ø  PROJECTS DEFINITION

• Gather the product data and the process used by the client

• Analyze the risks linked to the prodcuts and the processess in accordance with the specific regulations of the business

• Process to a gap analysis according to those regulations

• Define the process equipment and conceptual layouts of the premises

• Ensure the detailed implementation of the project based on room data sheets

• Realize risks analysis of the processes, impacts analysis and indentify the critical parameters and tests plans.

• Provide with the expertise in business specific processes (gowning, cleaning, environmental

monitoring, URS, ...)

         Ø  COORDINATION AND VALIDATION STRATEGY

• Establish a Validation Master Plan, Risks analysis (Impact Assessment) and Qualification Matrix;

• Master qualification methods (V-cycle, verification, ...) for the implementation of a strategy in the frame of the projects.

Ø  MANAGEMENT RESPONSIBILITIES

• Lead the “Regulatory & Compliance” department

• Follow-up with the skills of the “Regulatory & Compliance” department and organize trainings;

• Write and share the specific methods

• Provide with general training support to the team regarding the regulations of our business;

• Participate in the identification of new clients’ needs and ensure the development of the department by implementing new services and promote those to our potential future clients.


your contribution

Ø  QUALIFICATION

Master Degree in Industry Pharmacist (preferred), Civil engineer or bio-industrial engineer

Ø  EXPERIENCE

You have at least 3 years experience in the following:

• Industrial sector with a benchmarking in different types of industries.

• Quality Insurance

• Process Engineering

• Production or Validation/Qualification

• English confirmed



what do we offer?

We offer an attractive salary with extra-legal benefits: 

  • Group insurance
  • Hospitalization Insurance
  • Meal vouchers of 7 euros gross per working day
  • Reimbursement for km or company car 
  • Monthly allowance (50 euros net per month)
  • A 13th month
  • Training
  • Etc



summary
function
project manager (m/f)
employment type
full time, freelance
contract type
long term contracts
reference
CXRSP-92460
your Randstad contact
Olga Silitti
olga.silitti@cx.ausy.be 02/474.60.16
02/474.60.16