Senior Quality Assurance Specialist
Vor 2 Tagen
We are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Gi Group SA. As a key member of our quality assurance department, you will be responsible for ensuring the quality and compliance of our biologic manufacturing processes.
**Job Summary**
The Senior Quality Assurance Specialist will be responsible for implementing and maintaining quality processes, reviewing and approving operational elements, and assisting with continuous improvement initiatives. This role requires strong knowledge of pharmaceutical manufacturing processes, particularly in biologic drug substance production.
**Key Responsibilities**
Technical Responsibilities:
- Implementation of Manufacturing Execution System (MES) with regards to QM processes, including 'Review by Exception' concept during the project phase.
- Implementation and Maintenance of Quality processes for Review / Approval of master batch records/ executed batch records including writing of relevant procedures during the project phase.
- Review and release of purchased materials, internally manufactured materials including buffer/media assemblies, intermediates and drug substance including writing of relevant procedures during the project phase.
- 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.
Quality:
- Adheres to general cGMP rules, Quality policies, procedures and instruction as rolled out by the Quality function and endorsed by the site management.
- Actively contributes to continuous quality improvement initiatives and deviation reporting and follow-up.
EHSS:
- Adheres to general safety rules, policies, procedures and instructions as rolled out by the EHSS functions and endorsed by the site management.
- Actively contributes to safety initiatives and issues as well as near miss reporting and follow-up.
Values and Behaviour:
- Maintains commitment to Thermo Fisher Scientific values and adherence to ethics and legal compliance standards.
- Takes personal accountability for his/her presence, performance, and productivity for the achievements of defined objectives.
- Thinks and acts with a customer-centric mindset.
- Is intellectually curious and embraces Practical Process Improvement (PPI).
**Position Qualifications**
Education:**
- Pharmacist, Chemist / Biologist / Microbiologist / Biochemist or Immunolgist with master degree or higher.
Experience & Competencies:**
- 3-5 years in pharmaceutical industry (biotech company) and not less than 1 year in commercial batch release.
- Knowledge of pharmaceutical manufacturing processes with 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.
The estimated salary for this position is approximately €60,000 - €80,000 per year, depending on experience and qualifications. We offer a competitive compensation package and opportunities for career growth and development.
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Senior Quality Assurance Specialist
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