Quality Assurance Specialist Qualified Person (QP)

Company
A leading organization in the pharmaceutical industry dedicated to ensuring the highest quality standards in manufacturing and product development. The company operates under strict regulatory guidelines and values excellence, compliance, and continuous improvement.

Role Description
We are looking for an experienced Quality Assurance Specialist Qualified Person (QP) to oversee and ensure the quality and regulatory compliance of pharmaceutical products. This role involves coordinating product release, managing quality investigations, and supporting inspections and audits to uphold the company’s high standards in production.

Responsibilities
- Review and approve master documents and specifications to ensure compliance
- Initiate and evaluate quality investigations, making release or rejection decisions, and implementing improvement actions
- Complete deviation and investigation reports promptly and accurately
- Lead quality improvement initiatives to mitigate risks in production processes
- Authorize ongoing stability studies and product quality reviews
- Prepare for and manage inspections by government agencies and customers, including self-inspections and participation in overseas audits
- Handle product complaints, investigate causes, and coordinate recalls when necessary
- Maintain communication with external regulators, clients, and partners
- Support technology transfer activities and ensure smooth knowledge transfer processes
- Provide functional leadership to QA team members, including planning, structuring, and training staff

Requirements
- Degree in pharmacy, chemistry, biology, or a related field (per art 49 paragraph 2 directive 2001/83/EC)
- Over 5 years of experience in aseptic production, with knowledge of lyophilization and visual inspection preferred
- Strong understanding of pharmaceutical laws and regulations (EU and US)
- Proficiency in analytical methods and automated processes
- Decisive, results-oriented, and transparent communicators with a proactive approach

Other Information
If you are interested and want to apply, please submit your application via the apply button below and contact me.

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