Quality Assurance Associate (12 month contract)

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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.External 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.Description OverviewYou will act according to the Quality Assurance (QA) vision, strategy and standards for the integrated Corporate & Country QA group.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 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

• 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.

External 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 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