Quality Assurance Associate (h / f)

Perrigo; Châtillon; Sur place; EUR 40 000 - 80 000; Plein temps

Résumé du poste

An established industry player is seeking a Quality Assurance Associate to join their team in Châtillon. This role is pivotal in maintaining high-quality standards and compliance in the pharmaceutical sector. You will be responsible for ensuring adherence to critical procedures, supporting technical transfers, and conducting audits. The company values collaboration and offers a hybrid working approach, allowing flexibility to work from home. Join a team that prioritizes your professional growth and well-being while making a difference in health and wellness solutions for everyone.

Prestations

Flexible working hours

Career development opportunities

Health and wellness benefits

Collaborative work environment

Qualifications

• Master's degree in relevant fields or equivalent experience required.
• 3-5 years experience in Quality Assurance or Quality Control.

Responsabilités

• Ensure adherence to quality procedures and compliance with regulations.
• Support technical transfers and conduct internal audits.
• Provide QA training and evaluate effectiveness.

Connaissances

Quality Assurance

Regulatory Compliance

Technical Transfers

Problem Solving

Risk Management

Training and Development

Formation

Master's degree in Pharmaceutical Sciences

Equivalent experience

Outils

Quality Management System

Standard Operating Procedures

Change Control Process

Description du poste

At Perrigo, we are driven by our mission to Makes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All. We are proud to be a Top 10 player in the European Consumer Self-Care market and the largest U.S. store brand provider of over the counter and infant formula. Dedicated to providing The Best Self-Care for Everyone, we are the people behind the brands you trust. We are Opill, Compeed, Solpadeine, NiQuitin, ACO, and many more. We Are Perrigo. We are committed to enhancing the wellbeing of our colleagues and consumers alike. We pride ourselves on fostering an inclusive, collaborative culture where each person can experience a sense of belonging.

Join us on our One Perrigo journey as we evolve to win in self-care.

Description Overview

We are looking for a Quality Assurance Associate for our office in Chatillon. In this position you will be responsible for ensuring adherence to critical procedures and compliance and setting up and maintaining quality agreements with third parties (contract manufacturers, logistic service providers and distributors). You will assist with due diligence and integration of new product developments and new product introductions.

Scope of the Role

1. Support technical transfers, qualification and validation work.
2. Investigate quality incidents, deviations and complaints, identify and follow-up CAPA’s and supplier improvement plans together with third-party contract manufacturers.
3. Evaluate and follow-up Change Controls together with the Regulatory Affairs team.
4. Agree stability programs and review stability results.
5. Be part of third-party qualification and regular third-party auditing and assist in performing internal QA audits.
6. Support in the maintenance of the Quality Management System by creating and updating Standard Operating Procedures, Best Practices and Working Instructions.
7. Provide support in establishing and maintaining the Quality Management System.
8. Provide input to risk management plan and risk management file in line with ICH Q9 and ISO 14971.
9. Provide QA training to the entire group regarding QA systems and processes and evaluate training effectiveness.
10. Identify gaps and areas for improvement in QA processes and handling and lead remedial actions and initiatives.
11. You will support in data and document collection for regulatory purposes.
12. You will ensure ongoing inspection readiness in your area of responsibilities.
13. Coordinate Change control process and follow-up implementation of changes.
14. Provide evidence to perform review of implementation and effectiveness with regard to corrective and preventive actions.

Experience Required

1. Master degree in pharmaceutical sciences, engineering, biochemistry, chemistry or equivalent through experience.
2. Being approved as a Qualified Person (EU release of medicines) would be advantageous.
3. At least 3-5 years relevant experience in Quality Assurance / Quality Control / Production.
4. Good knowledge of the relevant European regulations for pharmaceutical products.
5. Knowledge of FDA regulations for pharmaceutical products is advantageous.
6. You are fluent in spoken and written English, other languages are an asset.

We believe our people are our greatest asset. Alongside competitive compensation, we offer benefits tailored to supporting you and your family, as well as career development opportunities to ensure you feel valued and supported, both professionally and personally.

Hybrid Working Approach

We love our offices and the setting they provide for in-person collaboration and celebration. But we also appreciate the opportunity to work remotely can energise you too, so we promote flexibility with the ability to work two days a week from home in many roles.

We are proud to be included in the Forbes list of "America's Best Employers by State 2024".

Applicants please note: To apply to this position please click the APPLY button at the bottom of the application. (The SAVE button will only save your profile information but not submit an application for this open position.) Thank you.

We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or other characteristics protected by law. #weareperrigo