Quality Assurance - QMS Senior Associate
Perrigo Company is dedicated to making lives better by bringing high quality and affordable self-care products that consumers trust everywhere they are sold. Help us do it.
We are looking for a Quality Assurance Senior Associate who can assist the Central Quality Assurance team in maintaining the integrated Quality Management System for the different product categories (Food, Food supplements, Medicines, Cosmetics, Medical Devices, Biocides). This position will be based at our Nazareth, Belgium location and will report to the Quality Systems Manager.
- Act according to the Quality Assurance (QA) vision, strategy and standards for the integrated Perrigo CSCI group.
- Support the maintenance of the Quality Management System as SME (including assessment and implementation of new regulations eg MDR)
- Ensure ongoing awareness of new and developing regulations (different ISO regulations, GMP, GDP, MDR, MDD etc)
- Identify gaps and areas for improvement in QA processes and lead remedial actions and initiatives.
- Maintain databases and documents according to good documentation practices and record retention procedure.
- Active support in the implementation, maintenance of Quality Systems, including electronical systems (including Trackwise, LMS),
- Support validation activities of electronic systems
- Provide QA training for Perrigo CSCI regarding QA systems and processes and procedures and evaluate training effectiveness.
- Support in the design and implementation of key performance indicators to verify efficiency and effectiveness of processes and procedures to agreed standards.
- Identify individual serious complaints that may result in market action or similar and to ensure adverse event complaints are identified and handed to safety group for evaluation and regulatory reporting.
- Ensure effective investigation (including non-conformity handling) of complaints and other deviations, including root cause analysis and defining CAPAs for short term and long term improvements.
- Active participation in the Monthly Complaint Review Meeting
- Evaluate and follow-up Change Controls together with the Regulatory Affairs team and other departments as required.
- Prepare Quality Agreements with third-parties (contract manufacturers, logistic service providers, distributors).
- Support / Perform internal QA audits.
- Ensure ongoing inspection readiness in your area of responsibilities.
- You will be based in the Perrigo offices in Nazareth (near Ghent), Belgium.
- Master’s degree in pharmaceutical sciences, engineering, biochemistry, chemistry … or equivalent through experience.
- At least 5 years relevant experience in QA in the pharmaceutical (or associated) industry.
- Knowledge of the relevant European regulations for pharmaceutical products (GMP, GDP), Medical Devices (MDR, MDD, ISO13485, ISO14971), Food, Food Supplements (HACCP, ISO 22000) Cosmetics (ISO 22716) is desired
- Self-starter, capable of working autonomously in an international environment.
- Clear communicator, practical and solution orientated.
- Enthusiastic work attitude
- 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.
- Not afraid to travel occasionally
- You can speak and write fluently in English. Other languages are an asset.