Quality Assurance Operations Specialist
vor 2 Monaten
Job Summary
We are seeking a highly skilled and experienced Senior Quality Assurance Scientist to join our team at Gi Group SA. As a key member of our quality assurance team, you will be responsible for ensuring the quality and compliance of our pharmaceutical products.
Key Responsibilities
- Implement and maintain quality processes for review and approval of master batch records and executed batch records, including writing of relevant procedures.
- Review and release of purchased materials, internally manufactured materials, including buffer/media assemblies, intermediates, and drug substance, including writing of relevant procedures.
- Review and approval of operational elements such as procedures and related documents, including specifications.
- Assist with continuous improvement initiatives related to quality documents and processes.
- Supervise the preparation of the Annual Product Review (APQR) and guarantee its execution within the due date.
Quality Assurance
You will adhere to general cGMP rules, quality policies, procedures, and instructions as rolled out by the Quality function and endorsed by the site management. You will actively contribute to continuous quality improvement initiatives and deviation reporting and follow-up.
EHSS
You will adhere to general safety rules, policies, procedures, and instructions as rolled out by the EHSS functions and endorsed by the site management. You will actively contribute to safety initiatives and issues as well as near miss reporting and follow-up.
Values and Behaviour
You will maintain commitment to Thermo Fisher Scientific values and adherence to ethics and legal compliance standards. You will take personal accountability for your presence, performance, and productivity for the achievement of defined objectives. You will think and act with a customer-centric mindset. You will be intellectually curious and embrace Practical Process Improvement (PPI).
Qualifications
- Pharmacist, Chemist/Biologist/Microbiologist/Biochemist or Immunologist with a master's degree or higher.
- 3-5 years of experience in the pharmaceutical industry (biotech company) and not less than 1 year in commercial batch release.
- Knowledge of pharmaceutical manufacturing processes with a particular focus on biologic drug substance.
- Fluent communication (oral and written) in German and English.
- Experience in SAP and electronic MES (manufacturing execution system) is an asset.
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