Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office
Job Description
Join Thermo Fisher Scientific Inc., a world-class leader in serving science, as a Senior Scientist QA Operations in our Engineering division. This is an outstanding chance to create a significant impact by ensuring that our pharmaceutical products are produced flawlessly and safely
Responsibilities:
* Ensure compliance of the manufacturing processes, batch records, deviations, change controls, and CAPA.
* Review and approve completed batch records within strictly defined timelines.
* Responsible for the technical batch release, ensuring products meet the highest standards.
* Provide active on-the-floor support during critical manufacturing steps.
* Evaluate and sanction operational documents, such as procedures, specifications, and working instructions.
* Assist with continuous improvement initiatives related to quality documents and processes.
* Supervise the preparation and execution of the Annual Product Quality Review (APQR).
* Adhere to and promote data integrity rules (ALCOA+).
* Make proposals to improve manufacturing flows, activities, and organization.
Qualifications:
* Pharmacist or scientist with a master's degree or equivalent experience.
* At least 3-5 years in the pharmaceutical industry, with not less than 1 year in commercial batch release.
* In-depth knowledge of pharmaceutical manufacturing processes, especially biologic drug substances.
* Proficient in German and English, with strong communication skills.
* Experience with SAP and electronic MES (Manufacturing Execution System) is an asset.
* Availability for on-call services and remote work as needed.
Be part of an ambitious team that strives for flawless execution and proven results. Apply your expertise to determine and successfully implement quality measures that compete at the highest level in the industry