Biotech Quality Assurance Specialist
Vor 3 Tagen
We are seeking a highly skilled and experienced Biotech Quality Assurance Specialist to join our team at Gi Group SA.
As a key member of our quality assurance department, you will play a critical role in ensuring the highest standards of quality in our biotechnology products.
This is an exciting opportunity for a professional with a strong background in pharmaceutical manufacturing processes, particularly in biologic drug substance production.
Your primary responsibility will be to implement and maintain quality processes, including the review and approval of master batch records and executed batch records. You will also be responsible for reviewing and releasing purchased materials, internally manufactured materials, and buffer/media assemblies.
In addition to your technical responsibilities, you will assist with continuous improvement initiatives related to quality documents and processes. This may include supervision of the preparation of the Annual Product Review (APQR) and ensuring its execution within the due date.
You will work closely with cross-functional teams to ensure that all activities are aligned with our company's values and adherence to general cGMP rules, quality policies, procedures, and instructions as rolled out by the Quality function and endorsed by site management.
To succeed in this role, you will need to have a strong understanding of pharmaceutical manufacturing processes and experience working with electronic MES systems. Fluency in German and English is essential, and experience with SAP is a significant advantage.
The ideal candidate will possess a Pharmacist, Chemist, Biologist, Microbiologist, Biochemist, or Immunologist degree with a master's degree or higher. A minimum of 3-5 years of experience in the pharmaceutical industry, with at least 1 year in commercial batch release, is required.
We offer a competitive salary package, with an estimated annual salary of $90,000 - $110,000, depending on qualifications and experience. If you are a motivated and detail-oriented professional looking for a challenging opportunity, please submit your application documents to us.
Key Responsibilities:
- Implement and maintain quality processes
- Review and approve master batch records and executed batch records
- Review and release purchased materials, internally manufactured materials, and buffer/media assemblies
- Assist with continuous improvement initiatives
- Supervise the preparation of the Annual Product Review (APQR)
Required Skills and Qualifications:
- Pharmacist, Chemist, Biologist, Microbiologist, Biochemist, or Immunologist degree with a master's degree or higher
- Minimum 3-5 years of experience in the pharmaceutical industry, with at least 1 year in commercial batch release
- Strong understanding of pharmaceutical manufacturing processes
- Experience working with electronic MES systems
- Fluency in German and English
- Experience with SAP is a significant advantage
About Us:
Gi Group SA is a leading recruitment agency specializing in the pharmaceutical industry. We are committed to providing exceptional service and connecting top talent with exciting opportunities.
Contact Information:
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