Job Opportunity: Senior Scientist - QA Operations
We are seeking an experienced Senior Scientist to join our QA Operations team. In this role, you will play a key part in ensuring the quality of our products through rigorous oversight and improvement of quality processes. If you are passionate about quality assurance and are looking for an opportunity to contribute significantly to our mission, we would love to hear from you.
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.
- Establish and maintain quality processes for the review and approval of master batch records and executed batch records, including the development of relevant procedures.
- Review and release purchased materials and internally manufactured materials, including buffer/media assemblies, intermediates, and drug substance, while also writing the relevant procedures.
- Provide review and approval for operational elements, such as procedures, related documents, and specifications.
- Support continuous improvement initiatives related to quality documents and processes.
- Oversee the preparation of the Annual Product Review (APQR) and ensure its execution is completed by the due date.
Quality
- Adhere to general cGMP rules, quality policies, procedures, and instructions as established by the Quality function and endorsed by site management.
- Actively contribute to continuous quality improvement initiatives and manage deviation reporting and follow-up.
EHSS
- Follow safety rules, policies, procedures, and instructions as outlined by the EHSS functions and approved by site management.
- Engage in safety initiatives and issues, as well as report and follow-up on near misses.
Values and Behavior
- Commit to Thermo Fisher Scientific values and adhere to ethical standards and legal compliance.
- Take personal accountability for your presence, performance, and productivity toward the achievement of defined objectives.
- Maintain a customer-centric mindset in all actions.
- Exhibit intellectual curiosity and embrace Practical Process Improvement (PPI).
Position Qualifications
Education
- Master's degree or higher in Pharmacy, Chemistry, Biology, Microbiology, Biochemistry, or Immunology.
Experience & Competencies
- 3-5 years of experience in the pharmaceutical industry (biotech preferred), with a minimum of 1 year in commercial batch release.
- Knowledge of pharmaceutical manufacturing processes, particularly in biologic drug substances.
- Fluent communication skills (both oral and written) in German and English.
- Experience with SAP and electronic MES systems is an asset.
Apply online using the form below. Please note that only applications matching the job profile will be considered.