Head of Quality Control
Vor 7 Tagen
Das Unternehmen
Die Canopy Growth Germany GmbH, Teil der börsennotierten kanadischen Canopy Growth Corporation, ist eines der führenden Cannabisunternehmen in Deutschland. Als Spectrum Therapeutics, unserer globalen Medizinmarke, entwickeln und vertreiben wir innovative Wirkstoffe auf Cannabinoid-Basis zur Herstellung von verschreibungspflichtigen Medikamenten für verschiedene Anwendungsgebiete, die das Leben von Patienten entscheidend verbessern können. Langjährige Erfahrung, wissenschaftliche Expertise und höchste Qualität machen uns zu einem Vorreiter auf diesem Gebiet in Deutschland. Als engagiertes und global agierendes Unternehmen bieten wir unseren Mitarbeitern vielfältige Entwicklungsmöglichkeiten in spannenden und abwechslungsreichen Positionen, in denen sie unsere Innovationskraft und Wachstumsstrategie aktiv mitgestalten können
The Opportunity
Reporting to the Senior Manager, Quality this will role will head the quality control function within our distribution facility in St.Leon Rot, BW. This is a limited contract of approximately 6 months to cover for maternity leave. Freelancers who wish to do an interim role will also be considered.
**Responsibilities**:
- Ensure all GMP requirements are met within quality control- Release or rejection for goods to Customers- Internal release or rejection of raw materials, packaging materials, intermediate products and bulk goods GMP evaluation /testing of laboratory results- Assessment/documentation of deviations or ‘out of specification’ procedures- Approval of specifications of sampling instructions, test methods and other quality control procedures according to AMWHV and EC GMP Guideline.- Regularly reviewing and adapting test instructions in accordance with AMWHV to the latest state of knowledge. Evaluation of test protocols and ensuring that all required tests are performed.- Planning / execution / reporting of analytical validations- Retention of reserve samples of materials and products- Coordination of recall actions and further activities after the occurrence of a potential hazard for patients- Ensuring that the rules of good Manufacturing practice to be taken into account in the testing of medicinal products- Coordination, supervision and evaluation of the quality assurance system in compliance with national and international legislation- Collection, documentation and Evaluation of the information on complaints from QC location and quality risks and if required provide information to the competent authorities- Carrying out self-inspections- Cooperation in authority inspections and customer audits and conduction performance audits relation to supplier qualification- Approval of the commissioning as well as supervision of laboratories working on a subcontracting basis Ensure GMP-compliant validation and qualification- Review and approval of qualification documents for facilities, equipment and rooms- Review and approval of process validation documents- Review and documentation of quality relevant changes (change control procedures)- Monitoring, documentation and correction of deviations (CAPA process)- Coordination and preparation of a management report, as well as the required PQRs (QC Part 26. Preparation of hygiene plans and monitoring of compliance and control of hygiene plans- Monitoring and control of environmental conditions- Definition of plans and limits for cleaning validation- Monitoring of GMP-compliant documentation- Establishment and maintenance of a system for archiving GMP documents (QC part) as well as support of QA in this regard- Compliance with occupational safety and EHS guidelines
Qualification and Experience- Good knowledge of pharmaceutical quality systems (GxP),- Have pharmaceutical quality control experience- Have completed pharmacy studies (Ph.D. preferred) with a license to practice pharmacy- Be a Qualified Person- Fluent in German and English (to a very good standad)
Other details- This is a full time, limited contract (6 months) based in Germany- This is primarily an on site position but some home office can be considered.
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