Quality Assurance Associate, QP (h/f)

Description générale

Périmètre du poste

•    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. 
 

Expérience requise

•    Master degree in pharmaceutical sciences, engineering, biochemistry, chemistry or equivalent through experience
•    Being approved as a Qualified Person (EU release of medicines)
•    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