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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.
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, email@example.com.
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.
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.
Master Degree in Industry Pharmacist (preferred), Civil engineer or bio-industrial engineer
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: