Beschreibung
We have a new opportunity for a Quality Systems Specialist to take support implementation of quality standard within Supply Chain department.Your daily tasks: Define, drive and deliver the successful implementation of processes and supporting systems together with stakeholders & partners in alignment with Supply Chain.
Ensure compliance of Supply Chain to Quality Manual and Procedures.
Support maintenance and improvements of the Supply Chain Quality system
Provide quality oversight and support the definition according GxP of the end to end processes within 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 Supply Chain.
Ensures the compliance of all Supply Chain processes against Quality Manual and GOPs/SOPs. Drives the optimization and ensures standardization of the quality of End to End Supply Chain processes.
Assess, and support implementation of new versions of Quality Modules within Supply Chain including GOPs/SOPs update coordination.
Support Quality Systems implementation and maintenance for Supply Chain including SOP management system and any compliance systems to be used for NTO Supply Chain.
Definition of the owned processes within 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 Supply Chain. Define the Operational Quality Manual for Supply Chain.
Coordinate the planning and execution of self-inspections within Supply Chain.
Coordination of external HA inspections or Global audits to Supply Chain.
Perform QA Decisions of deviations & complaints as required.
Requirements:
Bachelor degree in chemistry, pharmacy, biochemistry or equivalent. GMP training within pharmaceutical industry
2- 3 years of experience in pharmaceutical Quality Assurance in pharmaceutical production, quality control or supply chain. GMP knowledge.
Strong global and cross-functional leadership capabilities
Michael Bailey International is acting as an Employment Business in relation to this vacancy.