Job offer : Compliance Engineer/ Industrial Pharmacist
CoCEPTIO, business & technical expert active in niche areas (pharma, biotech, comestics, food-processing sector …) strives to be the best European stakeholder in the conception and implementation of high-valued industrial projects.
CoCEPTIO is also establishing an agile management where trust, autonomy and responsibilities are the key words for our associates, who enjoy the work environment and spontaneously contribute to the company growth.
Since its creation in 2016, CoCEPTIO has known a significant growth. That’s why CoCEPTIO is now looking for a Compliance Engineer/Industrial Pharmacist
1. Job description
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.
2. Operational responsibilities
2.1. 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
2.2. 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, …)
2.3. 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.
3. 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
Interested ? Please contact Mr. Thierry Marchandisse, HR officer by email at firstname.lastname@example.org or by phone: +32.4126.96.36.199