Quality Assurance Associate

il y a 2 semaines

Paris, Île-de-France Perrigo Company plc Temps plein

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 and French, other languages are an asset

We are based at Chatillon (92) just next to the Châtillon-Montrouge metro station (Line 13, T6) Flexible working is allowed with 2 days per week.

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