QA Change Control, IT Compliance and Serialisation Specialist
As a QA Change Control, IT Compliance and Serialisation Specialist you will contribute to the Quality team mainly at the Basel site and will report to the Head of Quality.
The primary objective is to ensure the impeccable quality of medicinal products with focus on the supervision of Change Control. Moreover, this role involves the management of the Serialisation Alert System, necessitating effective collaboration with internal and external stakeholders and the ongoing maintenance of the Pharmaceutical Quality System (PQS). In this capacity, support for various projects within Eumedica is expected. Staying abreast of the ever-evolving regulatory framework related to GxP principles is essential to ensure compliance.
The build-up of reliable IT compliance processes and the performance of computerized system validations rounds up the profile.
Ultimately, all responsibilities and accountabilities are in alignment with the established QA organization, ensuring the highest standards of quality, safety, and regulatory compliance are maintained across all aspects of medicinal product manufacturing and distribution
• Ensure proper handling of Technical Changes (request, review, follow up, closure, tracking) together with the Change Responsible and the QA Expert Managers
• Align with relevant stakeholders of the Technical Change Control for every change (e.g. meetings etc.)
• Lead the Technical Change Control Committee
• Maintain the Serialisation Alert system and update acc. to the latest guidelines
• Responsible for Master Data Set Up in Tracelink.
• Ensure that all serialization alerts are handled appropriately, document and escalate as needed
• Provide necessary guidance for Computerized System Compliance
• Conduct/Review and/or approve computer validation plans/reports, perform tests etc.
• Maintain the PQS
• Create, update and/or review Standard Operations Procedures
• Responsible for proper GxP-documentation (e.g. storage, data integrity)
• Perform employees training
Degree in pharmaceutical sciences or related fields with QA background
5 years practical experience in QA, QC or pharmaceutical production within a GxP industrial environment
Experience in IT compliance and/or validation of computerized systems
Experience in computerized systems, Microsoft Excel, etc.
Complete understanding and application of QA principles, concepts, industry practices and standards
Fluency in both written and spoken English
A position in a successful, fast-growing company
A dynamic and ambitious environment with very diversified tasks
The opportunity to create and build-up new processes
This position will be of 100%, unlimited contract, with preferred start date Jan 2024
Ready to take-up a new challenge?
Then please send your complete application dossier to: email@example.com.
We look forward to meeting you soon!