Sr Scientist QA Operations
vor 5 Monaten
When you’re part of the team at Thermo Fisher Scientific, you’ll do important work. And you’ll have the opportunity for continual growth and learning in a culture that empowers your development. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.
As part of the QA Operations Team of Fisher Clinical Services GmbH, Lengnau (LGN), the position holder is responsible to review and release recombinant Drug Substance including purchased material, internally manufactured material and intermediates. During the period of establishing the new manufacturing site, the position holder will be part of the facility program and will have to support the implementation of the necessary systems within the facility. In particular the position holder will have support different departments (such Manufacturing, Quality Control, Supply Chain, Engineering).
**Key responsibilities**:
- During Project Phase: Implementation of Manufacturing Execution System (MES) with regards to QM processes, including ‘Review by Exception’ concept
- Review and approval of operational elements such as procedures and related documents including specifications
- Assist with continuous improvement initiatives related to quality documents and processes.
- Supervision of the preparation of the Annual Product Review (APQR) and guarantees its execution within the due date.
- Be on the floor during critical manufacturing steps
- Respect and share data integrity rules (ALCOA+)
- Make proposal to improve flows, manufacturing activities and organisation
**Minimum requirements**:
- Pharmacist, scientific with master degree or higher. At least 3-5 years in pharmaceutical industry (biotech company) and not less than 1 year in commercial batch release.
- Knowledge of pharmaceutical manufacturing processes with particular on biologic drug substance
- Fluent communication (oral and written) in German and English.
- Experience in SAP and electronic MES (manufacturing execution system) is an asset.
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
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.
**Accessibility/Disability Access**:
-
Sr Scientist QA Operations
vor 5 Monaten
Lengnau, Schweiz Thermo Fisher Scientific Vollzeit**Work Schedule** Other **Environmental Conditions** Office When you’re part of the team at Thermo Fisher Scientific, you’ll do important work. And you’ll have the opportunity for continual growth and learning in a culture that empowers your development. With revenues of more than $40 billion and the largest investment in R&D in the industry, we...
-
Sr Scientist QA Operations
vor 5 Monaten
Lengnau, Schweiz Thermo Fisher Scientific VollzeitWhen you’re part of the team at Thermo Fisher Scientific, you’ll do important work. And you’ll have the opportunity for continual growth and learning in a culture that empowers your development. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make...
-
Sr Scientist QA Operations
vor 5 Monaten
Lengnau, Schweiz Thermo Fisher Scientific VollzeitWhen you’re part of the team at Thermo Fisher Scientific, you’ll do important work. And you’ll have the opportunity for continual growth and learning in a culture that empowers your development. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make...
-
Scientist, QA Systems
vor 5 Monaten
Lengnau, Schweiz Thermo Fisher Scientific VollzeitThermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or growing...
-
Manager, QA Systems
vor 3 Monaten
Lengnau, Schweiz Thermo Fisher Scientific Vollzeit**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Adherence to all Good Manufacturing Practices (GMP) Safety Standards **Manager, QA Systems & Compliance**: Thermo Fisher Scientific Inc. Lengnau is seeking an exceptionally qualified individual with a strong track record and experience in managing QA Systems & Compliance to join our team...
-
Manager, QA Systems
vor 3 Monaten
Lengnau, Schweiz Thermo Fisher Scientific Vollzeit: Lead and manage a team of 5-6 QA professionals, providing direction and support for their professional development. Provide oversight and supervision of the compliance activities within Lengnau site. Interact with varying levels of staff within the organization as well as with customers and auditors to determine and successfully implement compliance...
-
Scientist, QA Systems
vor 5 Monaten
Lengnau, Schweiz Thermo Fisher Scientific VollzeitThermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or growing...
-
QA Validation Expert
vor 5 Monaten
Lengnau, Schweiz Thermo Fisher Scientific VollzeitThermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving sophisticated analytical challenges, growing efficiency in their laboratories,...
-
Senior Quality Control Scientist
vor 4 Wochen
Lengnau BE, Bern, Schweiz ThermoFisher VollzeitUnlock Your Potential in Quality ControlThermo Fisher Scientific is seeking a highly skilled Senior Quality Control Scientist to join our Quality Control team at our PSG Large Molecules site in Lengnau. As a key member of our team, you will play a crucial role in ensuring the quality and integrity of our analytical equipment.Key Responsibilities:Lead the...
-
Senior QA Sterility Assurance Lead
vor 3 Wochen
Lengnau BE, Bern, Schweiz ThermoFisher VollzeitJob SummaryThis position is responsible for overseeing the day-to-day operations of the QA – Sterility Assurance team. The ideal candidate will have a strong background in microbiology and experience in the pharmaceutical industry.ResponsibilitiesDevelop and implement the Contamination Control Strategy and Sterility Assurance strategy for the site.Ensure...
-
Quality Assurance Manager
vor 3 Wochen
Lengnau BE, Bern, Schweiz ThermoFisher VollzeitJob SummaryThermo Fisher Scientific is seeking an exceptional individual to lead our QA Systems & Compliance team as the Manager of QA Systems & Compliance. This role requires a strong track record and experience in managing QA Systems & Compliance.Responsibilities:Lead and manage a team of 5-6 QA professionals, providing direction and support for their...
-
Senior Quality Assurance Manager
vor 3 Wochen
Lengnau BE, Bern, Schweiz Thermo Fisher Scientific VollzeitLead Quality Assurance TeamThermo Fisher Scientific seeks a seasoned Quality Assurance professional to lead our QA team in Lengnau. As Senior Quality Assurance Manager, you will oversee compliance activities, manage a team of 5-6 QA professionals, and ensure strict adherence to cGMP and associated procedures.Key Responsibilities:Manage and develop a team of...
-
Dspd Lab Scientist, Bioprocess Sciences Labs
vor 3 Monaten
Lengnau, Schweiz Thermo Fisher Scientific VollzeitThermo Fisher Scientific Inc. is a global leader in serving science with annual sales of more than $40 billion. Our mission is to help our customers make the world healthier, cleaner and safer. We support our customers advance life science research, solve complex analytical challenges, increase efficiency in their laboratories, improve patient health through...
-
Senior Quality Assurance Manager
Vor 2 Tagen
Lengnau BE, Bern, Schweiz Thermo Fisher Scientific VollzeitJob SummaryWe are seeking a Senior Quality Assurance Manager to lead our QA team and ensure compliance with cGMP regulations.Key ResponsibilitiesLead and manage a team of QA professionals, providing direction and support for their professional development.Provide oversight and supervision of the compliance activities within our site.Interact with staff,...
-
Quality Assurance Manager
vor 4 Wochen
Lengnau BE, Bern, Schweiz Thermo Fisher Scientific VollzeitLead QA ProfessionalThermo Fisher Scientific is seeking a highly skilled and experienced Lead QA Professional to join our team. As a key member of our quality assurance team, you will be responsible for leading and managing a team of QA professionals, providing direction and support for their professional development.Key Responsibilities:Lead and manage a...
-
Quality Assurance Manager
vor 1 Monat
Lengnau BE, Bern, Schweiz Thermo Fisher Scientific VollzeitLead QA ProfessionalThermo Fisher Scientific is seeking a highly skilled and experienced Lead QA Professional to join our team. As a key member of our quality assurance team, you will be responsible for leading and managing a team of QA professionals, providing direction and support for their professional development.Key Responsibilities:Lead and manage a...
-
Quality Assurance Manager
vor 2 Monaten
Lengnau BE, Bern, Schweiz Thermo Fisher Scientific VollzeitJob SummaryWe are seeking a highly experienced Quality Assurance Manager to lead our QA team and ensure compliance with regulatory requirements.Key ResponsibilitiesTeam Leadership: Lead and manage a team of 5-6 QA professionals, providing direction and support for their professional development.Compliance Oversight: Provide oversight and supervision of the...
-
Senior Quality Assurance Manager
vor 2 Wochen
Lengnau BE, Bern, Schweiz Thermo Fisher Scientific VollzeitJob Summary:We are seeking a highly experienced Senior Quality Assurance Manager to lead our QA team at Thermo Fisher Scientific. The ideal candidate will have a Master's degree in a life science field and at least 6 years of experience in quality assurance and regulatory compliance.Main Responsibilities:Lead and manage a team of 5-6 QA professionals,...
-
Quality Assurance Manager
vor 2 Monaten
Lengnau BE, Bern, Schweiz Thermo Fisher Scientific VollzeitQuality Assurance Manager **Key Responsibilities:** * Lead and manage a team of 5-6 QA professionals, providing direction and support for their professional development. * Provide oversight and supervision of the compliance activities within the site. * Interact with varying levels of staff within the organization as well as with customers and auditors to...
-
Senior Quality Assurance Manager
vor 2 Wochen
Lengnau BE, Bern, Schweiz Thermo Fisher Scientific VollzeitJob Summary:We are seeking a highly experienced Senior Quality Assurance Manager to lead our QA team and ensure compliance with cGMP regulations.Key Responsibilities:Lead and manage a team of QA professionals, providing direction and support for their professional development.Provide oversight and supervision of compliance activities within the site.Interact...
