Quality Assurance Associate

il y a 11 heures


Gent, Belgique Perrigo Temps plein

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 a blended-branded business to win in self-care.

**Description Overview**:
Perrigo is a leading global provider of over-the-counter (OTC) health products and wellness solutions that enhance individual overall well-being. Originating from the former Omega Pharma, the European branch is today present in 30 countries with a strong local anchorage.

You know us from brands like Physiomer, NiQuitin, XLS Medical, Zaffranax, Arterin, Dermalex, Biover, Galenco, Davitamon, Ymea, Lactacyd. Perrigo is an organization with a dynamic, transparent and fast-paced atmosphere, characterized by an entrepreneurial and cooperative culture.

We offer a Hybrid working schedule, a mix of onsite (3 days) and remote (2 days) working each week.

Please note that this is a 12-Month Fixed-Term Contract.

**Scope of the Role**:
**Your Responsibilities**:

- 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 ISO 9001 and ISO 13485 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.
- 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 QA 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.
- Coordinate quarantine shipments and ensure correct release of products that have been shipped under quarantine.
- Providing support in projects.

**Experience Required**:
**Your Qualifications**:

- Master degree in pharmaceutical sciences, engineering, biochemistry, chemistry or equivalent through experience.
- At least 3 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 an asset.
- Self-starter, capable of working autonomously at corporate level.
- Clear communicator, practical and solution orientated.
- Enthusiastic and get the job done mentality.
- Strong project management skills & team worker in a multicultural environment.
- Persistent drive for results in a fast-paced environment, utilizing sound project focus, organizational and problem solving skills.
- You are fluent in spoken and written English; other languages are an asset.

**Benefits**
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 develo


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