GxP Process Improvement - Biopharma QMS systems
GxP Process Improvement - Biopharma QMS systems
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1 Vacancy
Job Description
8 months contract CAPA Audit Change Deviation
Our customer is an innovative international biopharmaceutical company with offices in Basel. Intense R&D activities gave rise to an exciting pipeline of new promising many of which successfully reached commercialization stage. With a strong portfolio of onmarket products and an extensive portfolio of premarket assets company covers the entire value chain. Focus is put on latestage research and development patient access and commercialisation. Within the Global QA Team you will provide leadership together with the Process Owner for GxP regulated processes. You plan direct and communicate QMS processes to get aligned and structured in the new data Tool. QA Documentation like Deviations CAPAs Changes Audits tracked throughout the value chain of new biopharmaceuticals. You stand for functional regulated GxP processes in terms of global process strategy process effectiveness and continuous improvement. Your responsibilities: * Support proactive identification of needs for process standardization regulatory compliance direction and areas for improvement
- Raise awareness and understanding of the process requirements to the senior management of the function and cross functionally
- Support process owner by working with other stakeholders such as Quality the associated functional Quality & Compliance responsible to identify systemic process related issues and risks
- Develop process improvement needs from deviation trends findings in audits & inspection reports to drive corrective and preventative actions
- Leverage process excellence methodologies to drive continuous process improvement
You act as a change agent by partnering with key stakeholders to drive quality culture and embed a continuous improvement mindset Your profile: * > 3 5 years of experience in Pharma QMS QA Manufacturing and/or RA
- Experience in GxP operational environment
- Strong Project Management skills
- Knowledgeable of KPI and performance management systems
- Experience working in international organisation
Your have a strong communication high visibility a proactive mindset strong interpersonal skills. You have shown ability to collaborate in teams drive for results and solve complex situations and problems. You could successfully handle conflicts and create winwin situations in the past. You do have culture awareness and understanding the way of behaviour in different cultures. Apart from your technical skills you have a holistic business understanding and are fluent in English.
Employment Type
Full Time
