Description
One of our clients, an international company in the pharmaceutical industry, currently requires a Validation/RA Consultant with excellent knowledge of English.
Start: ASAP
Length: min. 6 months
Location: South of Brussels
FUNCTION DESCRIPTION
The Validation/Regulatory Consultant is involved in reviewing, translating and submitting Validation and RA reports.
KEY RESPONSIBILITIES
* Responsible for the lead and coordination for Core Files documents update, in collaboration with QA system organization.
* Manage and schedule with Production, Technical, Quality Control, Quality Assurance the writing/review process to ensure timely completion.
* Ensure the coordination with the departments involved in the writing/review process
* Writing CMC, "facility and equipment" parts and new files for US regulatory File.
* Writing and support US regulatory affairs Responses to Questions raised by Regulatory Authorities
* Monitor that supportive data provided by other departments arecompliant.
* Report significant issues
PREREQUISITES
Education
* University level (Life Sciences background is preferred) or equivalent by experience.
Knowledge
* Knowledge of regulatory procedures/systems/guidances
* Excellent level of spoken and written English
* Knowledge of biologic process and process equipment.
* Knowledge of Qualification/Validation principles.
* Knowledge of the EU/US variations policy.
Experience
* Experience in equipment Validation
* Experience in writing CMC (technical) parts of regulatory documents(registration files or variations).
* Experience working with Biologics (if possible preferred over Pharmaceuticals)
Skills
* Manages own time to meet agreed short-term targets
* Good communication skills
* Writing skills
* Analytical skills, creative and critical mind
* Ensures the coherence between contributions/quality of finalresults
* Team player
Tags:
Validation, Regulatory, RA, equipment, pharmaceutical