Location: Basel
Workload: 60-80%
Contract duration: 1 year, with possible extension
Responsibilities:
* QA oversight of qualification and validation activities for GMP-relevant plants and systems in drug substance and/or drug product manufacturing
* QA Oversight of CSV Systems
* Support the implementation of data integrity requirements.
* Review and approval of GMP documents (e.g. qualification plans, reports, change and deviation management, CAPAs, SOPs, risk analyses).
* Perform in-depth root cause analysis to solve complex problems.
* Driving optimization and improvement activities within IMP Quality
* Collaborate with stakeholders and contribute to the achievement of common goals
* Representing the area of responsibility during inspections by health authorities and internal audits.
* Supporting end-to-end cGMP activities and maintaining the right to operate
Requirements:
* Fluent in German is mandatory
* Academic degree in engineering, chemistry, life science, pharmacy or comparable
* At least 5 years of professional experience in the pharmaceutical industry, including at least 2 years in the field of Quality Assurance
* Min. 3 years of experience in plant qualification/validation
* Understanding of current data integrity (DI) requirements
* Knowledge of global quality and GMP requirements
* Proven success in inspections by health authorities and internal GMP audits
* Strong team player with excellent communication and influence skills