QA Manager Compliance, Systems and Inspections
Location: Basel
Duration: permanent
Responsibilities:
* End-to-end support of GMP inspections
* Proactive preparation of inspections for all IMP areas (organization and technical support of SMEs)
* Active role in the inspection (front office/ back office)
* Follow-up of the inspection (response process, follow-up of measures)
* Ensuring the timely and compliant fulfilment of all commitments made to the health authorities
* Interface with the Manufacturing network with regard to GMP inspections for holistic and proactive inspection preparation
* Supervision of the self-inspection program
* Support in the implementation of Data Integrity (DI) requirements
* Support of the QMS Business Process Managers in Quality Systems matters
* Responsible for the management and optimization of initiatives and improvements within IMP Quality Switzerland.
* Partnership with stakeholders and collaboration for the successful implementation of the IMP objectives
* Strong communication and matrix leadership in the context of GMP inspections
Requirements:
* Academic degree in natural sciences (pharmacy, chemistry or equivalent)
* At least 5 years of professional experience in the pharmaceutical industry, especially in the production of drug substance, drug product and finished product
* At least 5 years of professional experience in GMP inspections by health authorities and the current expectations of Swissmedic
* Excellent knowledge of global quality and GMP requirements
* In-depth understanding of current data integrity requirements
* Strong team player with high self-motivation and the ability to effectively influence others across all levels of the organization
* Fluent German and very good English skills are mandatory for this position
Seniority level: Mid-Senior level
Employment type: Contract
Job function: Quality Assurance
Industries: Pharmaceutical Manufacturing and Biotechnology Research
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