Quality Assurance Associate

Overview
In this fixed term contract role (CDD 6 months) as Quality Assurance Associate you will work within the quality department to support operational processes.
Scope of the Role
Ensure adherence to critical procedures and compliance to requirements for record retention.
Set up and maintain Quality Agreements with third-parties (contract manufacturers, logistic service providers, distributors).
Help with due diligence and integration of new product developments / new product introductions for assigned categories.
Support technical transfers, qualification and validation work.
Investigate quality incidents, deviations and complaints, identify and follow-up CAPA's and supplier improvement plans together with third-party contract manufacturers.
Evaluate and follow-up Change Controls together with the Regulatory Affairs team.
Review Product Quality Reviews.
Agree stability programs and review stability results.
Be part of third-party qualification and regular third-party auditing.
Assist in performing internal QA audits.
Support in the maintenance of the Quality Management System by creating and updating Standard Operating Procedures, Best Practices and Working Instructions.
Provide support in establishing and maintaining the Quality Management System
Provide input to risk management plan and risk management file in line with ICH Q9 and ISO 14971
Provide input for analysis of data and/or management review
Provide QA training to the entire group regarding QA systems and processes and evaluate training effectiveness.
Maintain databases and documents according to good documentation practices and record retention procedure.
Assist in the GDP administrative batch control procedure.
Assist in EU QP release of medicinal products in line with the applicable regulations.
Identify gaps and areas for improvement in QA processes and handling and lead remedial actions and initiatives.
Keep a going awareness of new and developing regulations related to GDPs and GMPs.
You will follow up on actions of complaints if requested.
You will support in data and document collection for regulatory purposes.
You will ensure ongoing inspection readiness in your area of responsibilities.
Coordinate Change control process and follow-up implementation of changes.
Provide evidence to perform review of implementation and effectiveness with regard to corrective and preventive actions.
Experience Required
Master degree in pharmaceutical sciences, engineering, biochemistry, chemistry or equivalent through experience
Being approved as a Qualified Person (EU release of medicines) would be advantageous
At least 3-5 years relevant experience in Quality Assurance / Quality Control / Production
Good knowledge of the relevant European regulations for pharmaceutical products
Knowledge of FDA regulations for pharmaceutical products is advantageous
You are fluent in spoken and written English, other languages are an asset
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