Job Description
An exciting new opportunity has arisen to join as Quality Assurance Qualification Expert for our Biotech drug substance plant.
Your Role:
You will provide QA expertise for Equipment Qualification/Requalification, Sterilization qualification, Cleaning Validation, Raw Material Qualification, Process & Analytical Validation, and Computerized System Validation.
Key Responsibilities:
* Elaborate qualification/validation strategies
* Review and approval of protocols and reports
* Participate in risk analysis and identify gaps
* Purpose remediation plans and act as Quality Subject Matter Expert on specific topics
* Review and/or approve qualification/validation documents, risk assessment, SOPs and take quality decisions according to company standards
Requirements:
* University or relevant engineering degree
* Hands-on experience of equipment Qualification/Validation in the pharmaceutical industry
* At least 2 years' experience in a quality environment in pharmaceutical industry or equivalent, ideally in biotechnology
* Knowledge in cGMP and health authority expectations
* Knowledge in Data Integrity (a plus)
* Experience in Equipment (Utilities/E&M/Production/Lab equipment)
* Good interpersonal skills with positive attitude and ability to support colleagues
* Good writing skills
* French written and spoken, English good written skills