Senior Manager QA/RA Projects Lead
vor 2 Wochen
We are seeking a highly experienced Senior Manager QA/RA Projects to join our team at Gi Life Science.
As a key member of our Quality Assurance and Regulatory Affairs team, you will be responsible for ensuring the quality and compliance of our pharmaceutical products.
Key Responsibilities- Ensure that each product is manufactured, packaged, and tested in compliance with regulatory requirements.
- Collaborate with cross-functional teams to ensure the quality and compliance of our products.
- Act as the deputy of the Responsible Person and Qualified Person, ensuring compliance with regulatory requirements.
- Coordinate and drive quality activities related to technology transfer, analytical transfer, raw materials introduction, supplier qualification, and manufacturing specifications.
- Conduct assessments of change controls and act as the site interface with Global Regulatory.
- Support responses to regulatory authorities and ensure compliance with laws concerning health and security of workers.
- BSc or MSc degree in Pharmacy, Chemistry, Microbiology, or related science.
- Minimum 7 years of experience in Quality Assurance, Quality Control, and/or Regulatory Affairs in a pharmaceutical company or related industry.
- Solid understanding of cGMPs and Swiss, EU, and FDA regulatory requirements.
- Excellent investigational and QA problem-solving skills.
- Language: French and English.
Gi Life Science is a leading pharmaceutical company dedicated to delivering innovative solutions for the healthcare industry.
We are committed to excellence and strive to create a work environment that is collaborative, inclusive, and supportive of our employees' growth and development.
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