Description
One of our clients, a multinational company in the pharmaceutical industry currently requires a Chemical Risk Specialist
Start: August/September
Length: Min. 12 months
Location: South of Brussels
FUNCTION DESCRIPTION:
- The contingent will actively participate to the chemical risk securization project leaded by the quality assurance department and procurement.
- The candidate will be in charge of risk assessments and remedial ofactions for critical area's related to the management of chemical and biological materials
entering the manufacturing process of vaccines.
FIELD ACTIVITY:
- Specification gap analysis versus pharmacopeia (EP, USP, Chinese pharmacopea, ) and supplier CoA- Selection of new suppliers and/or materials
- Qualification of alternative material and/or suppliers
- Impact assessments versus regulations (reach, HALAL)
- Business continuity risks
The contingent will have to interact with following departments
- Production departments using the selected chemicals and biological materials
- Procurement
- Global Quality Assurance department
- QC
KEY RESPONSIBILITIES:
Incoming material specification:
* Perform gap analysis between specifications and regulatory requirements (Japanese Pharmacopea, USP, EP, Regulatory files, New standard for impurities, HALAL, REACH, material grade, new material
Classification rules)
* Review of Incoming material specifications to be aligned with the client's and regulatory requirements
* Assess QC capabilities related
* Peform risk assessments related to endotoxin and microbiological content
Selection/qualification of alternative suppliers/materials:
* Selection/Identification of alternative suppliers supplying material meeting the client's specifications and expectations
* Qualification of new suppliers/incoming materials according to theclient's requirements
PREREQUISITES:
- Education:
Scientific university degree (Pharmacist, engineer or equivalent)
- Specific skills:
Polyvalent, autonum, leadership skills
- Knowledge:
Fluent in English (spoken and written)
EXPERIENCE:
Experience in Management of incoming materials in a pharmaceutical environment (specification management, pharmacopeia)
Tags:
Chemical, Risk, Management, Pharmaceutical, Pharmacopeia, Halal,REACH, HALAL, Risk Assessment, évaluation des risques