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QPS ENGINEERING AG
ist ihr Partner für eine erfolgreiche Zukunft. Wir sind stetig auf der Suche nach Personal das für die Qualität unserer Branche verantwortlich ist. Mit unserer „Engineering Abteilung“ sind wir in der Pharmaindustrie (GxP Umfeld) beim Kunden vor Ort tätig. Für diesen Bereich sind wird auf der Suche nach QA Experten die neue Erfahrungen sammeln und Ihre bisherige mit dem Team auch teilen möchten.
Major Accountabilities:
implement and support global AS&T programs in External Supply.
• Defines and implements the business processes and SOPs necessary to maintain a robust Quality System within External Supply affecting the laboratory activities (e.g. management of changes, maintenance of testing monographs)
• Support Implementation of Guidelines at external partners and suppliers
• Lead programs and initiatives to implement changes and to remediate where required
• Interprets stability data, analyzes trends, and provides scientifically sound conclusions to support assignment and monitoring of product shelf life, storage conditions, packaging and transport categories. Provide corrective actions to address immerging stability issues.
• Support External Suppliers Qualification process
• Support Tech Transfer assessments for analytical method transfers.
• Lead QC aspects of Technical meetings with the External suppliers and establish good working relationships with clear communication and defined actions and goals.
• Support assessments of analytical Change Control records for acceptability. Define studies needed to support the changes.
• Interacts with the External Supplier to guarantee suspect analytical results investigations are managed in agreement with standards and the right CAPA is implemented.
• Ensure Testing Monographs are state-of-the-art with respect to technique and technology, and in line with registration documentation. Support programs and initiatives to implement changes to, and upgrade Testing Monographs where required
• Support site readiness for Health Authority inspections & participate in audits on request.
• Escalate any issues or instances of instability per the escalation policy, and initiate any market action that is required.
• Support analytical trouble shooting as needed.
KPIs:
Number and severity of cGMP issues identified during audits (internal, GCA, HA)
• ESO performance evaluated by the department KQIs
Impact on the organization:
High within the range of GMP compliance
Ideal Background:
University degree in Pharmacy, Biochemistry, Chemistry, or another related science
Fluent in speaking / writing in English
5-8 years experience in the pharmaceutical industry
Mind. 5 years experiences in QC, method development, validation or stability testing
Thorough knowledge of cGMP requirements.
Thorough knowledge of cGMP, ICH guidelines, regulatory requirements & risk management. .
Good leadership skills and experiences in leading project teams
Strong track record in project management
Place: Basel
Sie möchten mit uns wachsen und erfüllen zum grössten Teil die genannten Anforderungen, dann kontaktieren Sie uns, wir für freuen auf Ihre kompletten Bewerbungsunterlagen (Anschreiben, Lebenslauf, ggf. Arbeitszeugnisse). Wir möchten Ihnen eine erfolgreiche Zukunft bieten!
Unterlagen an: Sergej Ruppel (Leitender Projektingenieur) Email s.ruppel@qps-ag-ch