Kontroler Jakości

The Quality Systems specialist shall ensure maintenance on a compliance status of the QA Biologics, Generic and Medical Device quality systems, ensuring compliance with corporate standards and current regulatory requirements. Ensure compliance in training processes and systems and is capable in all QA IT system applications. In addition, this person shall support the management of supplier qualification, in order to maintain the documentation (Quality Agreement, Product Quality Complaint, Product Quality Review and CMO Assessment, change control, deviations) organized, reviewed and archived.

Support and maintain the Quality Management System in a compliant state by ensuring timely assessment of global corporate standards in comparison with current local procedures and current authorities' expectations.
Ensure timely implementation of global standards and procedures in the Quality unit by execution of associated GAP assessments against current local procedures in addition to executing any necessary implementation activities associated.
Responsible for execution of training programs as per training systems ensuring timely completion of training requirements from all employees (management of training curriculums, coordination of continuous trainings etc.) including annual GMP training coordination, on the job training and induction trainings.
Coordinate the review of CMO and Affiliates Quality Agreement with QPs.
Responsible for Quality Agreement Documentation archive.
Responsible for issuing quality metrics and trend evaluation
Support the Quality Management Review process by organizing the meetings presentation, metrics of complaints, deviations and changes controls
Complaint Management for The Netherlands, Nordic countries, CMOs and Third Parties
Responsible SME for Training Management system in Sun Europe - Learning Management System
in Track wise software in roles such as initiator/reviewer or approver wherever applicable.
Support management of SOPs in eDMS software

HBO or Bachelor Degree in (Bio-) Chemistry, Pharmacy, biological science or similar education.
Minimum of 3 years of relevant experience in (bio) pharmaceutical GMP environments.
Well versed in Microsoft Excel, PowerPoint and MS Word.
Fluent in English

Minimum 5 years of experience in the pharmaceutical industry
Experience in Manufacturing, QA/QC, Country QA Office

Knowledge and experience in (bio-) pharmaceutical operations, QA/QC processes and contract manufacturing.
cGMP experience and knowledge, QA/QC and regulatory compliance (US, EU and other international agencies)
Experience in quality management system as training, internal audit, change controls, deviations in regards to management and continuous improvement.
Experience with electronic Document Management, Training systems and Trackwise
Knowledge of MS office and Windows based computer applications.

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