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Quality Assurance Associate
il y a 2 semaines
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Quality Assurance Associate (h/f) Associé en assurance qualité - CDD 6 mois
Location:
Chatillon, FR, 92320
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
Apply now »
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