You oversee compliance and enhance quality processes in manufacturing, actively supporting operations while managing batch records and reviewing documentation.
Anforderungen
- •Master's degree in Life Sciences
- •At least 3 years experience in pharma
- •Knowledge of pharmaceutical manufacturing
- •Proficient communication skills in German
- •Proficient communication skills in English
- •Experience with SAP is an asset
- •Experience with electronic MES is an asset
- •Availability for on-call services
- •Remote work availability based on needs
Deine Aufgaben
- •Ensure compliance of manufacturing processes and records.
- •Review and approve completed batch records promptly.
- •Manage technical batch release responsibilities.
- •Provide on-the-floor support during critical manufacturing steps.
- •Review and approve procedures and related documents.
- •Assist with continuous improvement of quality documents.
- •Supervise preparation of the Annual Product Review.
- •Maintain and communicate data integrity rules.
- •Propose improvements to manufacturing processes and organization.
Original Beschreibung
# Sr Scientist QA Operations
**Lengnau, Switzerland** | **Full time** | **Fully Onsite**
**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
**Job Description**
Looking to contribute to a team with outstanding chances to define global impact? As a Sr Scientist QA Operations at Thermo Fisher Scientific Inc., you'll lead production and drug release for innovative pharmaceutical solutions.
## Responsibilities:
* Ensure compliance of manufacturing processes, batch records, deviations, change control, and CAPAs.
* Review and approve completed batch records within defined timelines.
* Responsible for technical batch release.
* Provide active on-the-floor support during critical manufacturing steps.
* Review and approve operational elements such as procedures and related documents, including specifications, working instructions, and impact assessments.
* Assist with continuous improvement initiatives related to quality documents and processes.
* Supervise the preparation of the Annual Product Review (APQR) and ensure its timely execution.
* Maintain and share data integrity rules (ALCOA+).
* Propose improvements to improve flows, manufacturing activities, and organization.
## Qualifications:
* Master's degree or higher in Life Sciences (e.g., Chemistry, Biochemistry, Biology, Pharmacist).
* At least 3-5 years of experience in the pharmaceutical industry (biotech company) with a minimum of 1 year in commercial batch release.
* Knowledge of pharmaceutical manufacturing processes, especially biologic drug substances.
* Proficient communication skills in German and English.
* Experience with SAP and electronic MES (manufacturing execution system) is an asset.
* Availability for on-call services and remote work based on department needs.