Act according to the Quality Assurance (QA) vision, strategy and standards for the 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 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.
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.