**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Adherence to all Good Manufacturing Practices (GMP) Safety Standards **Job Description** **Technical Responsibilities** **Processes and methods implementation:** + Coordinate actions to establish and implement processes and analytical methods for testing finished products, in-process controls, intermediates, raw materials, utility, and cleaning samples. + Responsible for: + Write and revise standard operating procedures (SOPs) and work instructions (Wis) within timelines + Review and approve methods, plans, protocols, and reports + Supporting procurement, qualification, calibration, and maintenance of analytical and infrastructure equipment + Coordinate the development, transfer, and validation of analytical procedures according to given timelines + Review of analytical raw data, equipment qualification/maintenance raw data, and other documentation in Biochemical QC. **Project Leadership:** + Represent BCQC in projects, workgroups, and participate in local and global initiatives + Promote effective and timely communication within project teams, ensuring visibility and understanding of the site/company's strategy + Support project implementation within the QC department and ensure data-driven workload for each assigned project + Drive project collaboration and operate in full alignment with the company's core values + Own the problem-solving process for any issues related to assigned projects/tasks + Coordinate resources in collaboration with the rest of QC, ensuring QC timelines and targets are met + Promote an accountable working environment through management mentorship and open access to important information + Proactively support continuous improvement of QC compliance and performance + Establish and maintain contact with external partners such as suppliers, contract laboratories, and universities **QC Execution:** + Document and deposit raw data, results, reports, and journals + Assist during the resolution of issues and requests related to (bio)chemical analytics (quality issues, health authority requests, etc.) + Ensure timely investigation of deviations + Communicate efficiently and inform the head of BCQC about ongoing business and issues + Sharing required information with sponsors, customers, and colleagues + Supporting QC colleagues in the areas of GMP and Quality Control + Supporting recruitment within the team + Acting as liaisons between their respective departmental teams and the DI officer, ensuring regular DI Surveillance and performing internal DI moments, huddles, and trainings **Position Qualification** Education: + Degree or equivalent experience (Master or higher) in biochemical, chemical, pharmaceutical, molecular sciences, or similar fields. + Lower educational background may be accepted based on significant experience in the pharmaceutical industry. **Experience & Proficiencies:** + 3-5 years lab experience with confirmed expertise in (bio)chemical QC methods, method validation, and analytical issue management + confirmed experience (at least 5 years) in chemical or biochemical laboratories, including experience in a regulated GMP environment + experience in project and task coordination **Proficiencies:** + Business insight and critical thinking + Emphasis on achieving goals and taking ownership + Effective communication skills + Strong collaboration abilities + Agility and adaptability in handling ambiguity **Additional Requirements:** + Proficiency in English and German is required, with exceptions considered on a case-by-case basis based on the overall CV. Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.