Quality Assurance Associate - Nazareth, België - Perrigo

Perrigo

Geverifieerd bedrijf

Nazareth, België

1 week geleden

Geplaatst door:

Sophie Dubois

beBee Recruiter

Beschrijving

Perrigo Company is dedicated to making lives better by bringing Quality, Affordable Self-care products that consumers trust everywhere they are sold.

Help us do it.

Description Overview:

You will join our Quality Assurance team and contribute to the QA vision, strategy and standards for the integrated Corporate & Country QA group.

You will have the opportunity to work on important procedures and manage compliance/requirements for record retention.

As part of this role you will manage and maintain Quality Agreements with third-parties (contract manufacturers, logistic service providers, distributors), while helping with due diligence and integration of new product developments / new product introductions for assigned categories.

Scope of the Role:

Support technical transfers, qualification and validation work.
Investigate quality incidents, deviations and complaints, identify and followup CAPA's and supplier improvement plans together with thirdparty contract manufacturers.
Evaluate and followup Change Controls together with the Regulatory Affairs team.
Review Product Quality Reviews.
Agree stability programs and review stability results.
Be part of thirdparty qualification and regular thirdparty 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 1497
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 followup 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:

At least 5 years relevant experience in Quality Assurance / Production.
Good knowledge of the relevant European regulations for cosmetic products and / or pharmaceutical products.
Knowledge of FDA regulations for pharmaceutical products is an asset.

We are seeking a diverse applicant pool to ensure the diversity of our team reflects the end consumers we serve through our self-care mission.

We are proud to be an equal opportunity employer that celebrates our team's differences.

Individuals of all races, ethnicities, nationalities, ancestries, religious creeds, sexual orientations, genders, gender identities and gender expressions, national origins, ages, mental and physical abilities, familial status,' veterans status', military status' and more are encouraged to apply.

TOGETHER, we make lives better. #DIV