Join Our Team as a Senior Scientist in QA Operation
We are seeking a dedicated and experienced Senior Scientist to play a crucial role in our Quality Assurance (QA) Operations team. If you are passionate about maintaining the highest standards in the pharmaceutical industry and possess the right qualifications, we encourage you to apply online using the form below.
Position Responsibilities & Accountabilities
Technical Responsibilities
- During the Project Phase: Implement the Manufacturing Execution System (MES) concerning Quality Management (QM) processes, including the 'Review by Exception (RbE)' concept.
- Implement and maintain quality processes for the review and approval of master and executed batch records, including writing relevant procedures.
- Oversee the review and release of purchased and internally manufactured materials, including buffer/media assemblies, intermediates, and drug substances, along with drafting associated procedures.
- Review and approve 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) to ensure its execution within the due date.
Quality
- Adhere to general cGMP rules, quality policies, procedures, and instructions as implemented by the Quality function and endorsed by site management.
- Actively contribute to ongoing quality improvement initiatives, deviation reporting, and follow-up.
EHSS (Environmental, Health, Safety, and Security)
- Comply with general safety rules, policies, procedures, and instructions as instructed by EHSS functions and endorsed by site management.
- Actively contribute to safety initiatives, report issues, and engage in near-miss reporting and follow-up.
Values and Behavior
- Commit to Thermo Fisher Scientific values and adhere to ethical and legal compliance standards.
- Take personal accountability for your presence, performance, and productivity in achieving defined objectives.
- Maintain a customer-centric mindset in all activities.
- Exhibit intellectual curiosity and embrace Practical Process Improvement (PPI).
Position Qualifications
Education
- Pharmacist, Chemist, Biologist, Microbiologist, Biochemist, or Immunologist with a Master's degree or higher.
Experience & Competencies
- 3-5 years of experience in the pharmaceutical industry (biotech company) with a minimum of 1 year in commercial batch release.
- Strong knowledge of pharmaceutical manufacturing processes, particularly in biologic drug substances.
- Fluent in both German and English (oral and written communication).
- Experience with SAP and electronic MES (Manufacturing Execution System) is an asset.
Please note that only applications matching the job profile will be considered.