Job Opportunity: Sr. Scientist - QA Operations
We are seeking a highly skilled Sr. Scientist in QA Operations to join our dynamic team. The ideal candidate will possess a strong background in quality assurance within the pharmaceutical industry, specifically in biotech. This role emphasizes the implementation of quality processes and compliance with cGMP standards.
Position Responsibilities & Accountabilities
Technical Responsibilities
- During the project phase, you will implement the Manufacturing Execution System (MES) in relation to Quality Management processes, including the 'Review by Exception (RbE)' concept.
- Responsible for the implementation and maintenance of quality processes for the review and approval of master batch records and executed batch records, including the drafting of relevant procedures.
- Review and release purchased materials as well as internally manufactured materials, including buffer/media assemblies, intermediates, and drug substances, while also writing pertinent procedures during the project phase.
- Review and approve operational elements such as procedures, related documents, and specifications.
- Assist in continuous improvement initiatives related to quality documents and processes.
- Supervise the preparation of the Annual Product Review (APQR) and ensure its execution within the specified timeframe.
Quality Assurance
- Ensure adherence to cGMP regulations, quality policies, procedures, and instructions as defined by the Quality function and supported by site management.
- Actively participate in continuous quality improvement initiatives and contribute to deviation reporting and follow-up.
Environmental Health, Safety, and Sustainability (EHSS)
- Follow general safety rules, policies, procedures, and instructions as outlined by the EHSS function and endorsed by site management.
- Contribute actively to safety initiatives, reporting, and follow-up on near misses.
Values and Behavior
- Commit to Thermo Fisher Scientific's values while adhering to ethical and legal standards.
- Take personal accountability for your presence, performance, and productivity towards achieving defined objectives.
- Exhibit a customer-centric mindset in all actions and decisions.
- Demonstrate 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
- A minimum of 3-5 years of experience in the pharmaceutical industry, specifically in a biotech company, with at least 1 year in commercial batch release.
- Strong knowledge of pharmaceutical manufacturing processes, particularly focused on biologic drug substances.
- Fluency in both German and English, with excellent oral and written communication skills.
- Experience with SAP and electronic MES (Manufacturing Execution Systems) is an advantage.
To apply, please apply online using the form below. Please note that only applications matching the job profile will be considered.