Perrigo Company

Description 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