For our customer located in Basel/Klybeck/Switzerland we are currently looking for (m/f) a QA Compliance Manager
- Type of placement: 12 months, external contract with possible long term extension
- Company: major Pharma company in Basel area
- Salary: please ask us for the exact rate range
Correct Titel: Quality Systems and Compliance Manager
- Establish and implement processes within NTO Supply Chain to ensure compliance to quality standards.
- Define, drive and deliver the successful implementation of processes and supporting systems together with stakeholders & partners in alignment with NTO Supply Chain.
- Ensure compliance of Supply Chain to our customer Quality Manual and Procedures.
- Support maintenance and improvements of the NTO Supply Chain Quality system
- Provide quality oversight and support the definition according GxP of the end to end processes within NTO Supply Chain (e.g. Master Data Governance, Artworks, Lifecycle Management)
Ensure compliance with GxP and regulatory requirements and continuous improvement of quality relevant processes within NTO Supply Chain.
- Ensures the compliance of all NTO Supply Chain processes against Quality Manual and GOPs/SOPs of our customer. Drives the optimization and ensures standardization of the quality of End to End NTO Supply Chain processes.
- Assess, and support implementation of new versions of Quality Modules within NTO Supply Chain including GOPs/SOPs update coordination.
- Support Quality Systems implementation and maintenance for NTO Supply Chain including SOP management system and any compliance systems to be used for NTO Supply Chain.
- Ensure that Key Represent NTO Supply Chain QA on the definition of the Quality Systems to be applied ensuring that any specific aspects for Supply Chain are considered and support implementation as required.
- Definition of the owned processes within NTO Supply Chain (e.g. deviation, complaint and escalation).
- Quality Indicators (KQI) are collected and reported on time on a monthly basis for relevant processes.
- Provide QA oversight to ensure that GxP training and organization charts are updated and filed regularly within NTO Supply Chain. Support in the definition of GxP relevant training for NTO Supply Chain.
- Define the Operational Quality Manual for NTO Supply Chain.
- Coordinate the planning and execution of self-inspections within NTO Supply Chain.
- Coordination of external HA inspections or Global audits to NTO Supply Chain.
- Perform QA Decisions of deviations & complaints as required.
- Certified investigator.
- Support as required IGM Coordinator for NTO Supply Chain QA that records are archived according to defined process and timelines.
- Bachelor degree in chemistry, pharmacy, biochemistry or equivalent. GMP training within pharmaceutical industry
- Desirable: IT systems knowledge.
- English - fluent, other languages mainly German preferred
- 2- 3 years of experience in pharmaceutical Quality Assurance or 2-5 years of experience in pharmaceutical production, quality control or supply chain. GMP knowledge.
- Strong global and cross-functional leadership capabilities
- Intercultural experience and ability to act in a com-plex and rapidly changing business environment
- Desire experience with systems mainly SAP
- Strong influencing and change management skills on a global scale in order to indirectly manage global network of participants in change projects
Kindly be informed that this job offer is from our customer in Switzerland. Therefore we can only accept applications within the EU or applicants with Swiss work permissions.
Please attach your CV in Word format.
SimplyVision is looking forward to your application.