![ALTOGEN AG](https://media.trabajo.org/img/noimg.jpg)
Quality Assurance and Pharmacovigilance Expert
vor 2 Wochen
**COMPANY**
**ALTOGEN** is a Swiss engineering and consulting company specialized in life sciences with expertise in pharmaceuticals, biotechnology, medical devices.
With several years of experience, technical expertise and project coordination, we support our partners throughout all areas of the product life cycles.
We surround ourselves with junior to expert level consultants with strong development potential, whom we support in their professional goals.
**ABOUT THE JOB**:
- To represent PVQA for Pharmacovigilance System
- To support company/ Supplier/Vendor teams (e.g. GDS, GMA, Marketing, affiliate) in staying compliant with regulatory requirements (e.g. answering questions; participating to meeting to discuss PV issues)
- To help/complete PSMF part under responsibility of PVQA
- To escalate serious / continuing non-compliance PV issues as appropriate/necessary
- To organize and/or help with trainings on PV requirements
- To organize and/or help presentation on PV important topics (e.g. PVQA audit finding, PV
inspection)
- To help/contribute to PV process improvements (e.g. via audit finding / CAPA)
- To manage PV deviation as per Deviation QS documents
- To help/contribute to PV electronic systems (e.g. Testing Quality Event Module)
- To help with trouble shooting for Idorsia processes and systems
- To contribute to obtain efficient Pharmacovigilance as indicated by relevant Key Performance Indicator (KPI)
- To lead/participate in management of PV inspections (e.g. preparation, follow up) by (international) regulatory authorities
- To facilitate the PV inspection CAPAs elaboration, approval and follow-up for PVQA manager expected to be also an PVQA Auditor as defined in company’s SOP-101134:
- To work as per the defined strategy for the global PV audit program
- To plan, perform, and report standards GVP audits (e.g. affiliate, supplier, process, studies)
- To be in charge of CAPAs evaluation/review follow-up and closure
- To assist Senior colleagues
- To perform any other PVQA task that could help to achieve a high adherence to PV requirements
**ABOUT YOU**:
- At least a bachelor degree or equivalent education/degree in Life sciences or healthcare
- At least 3 years of experience within pharmaceutical industry/health authority
- Good knowledge of GVP regulatory requirements and pharmaceutical industry practices
- At least 1 year experience in Quality Assurance (QA) within the GxP environment (alternatively experience in operational / regulatory department / safety/pharmacovigilance operation / department with a role implying quality work could be also considered equivalent)
- Experience in GxP quality systems, compliance monitoring, CAPA management, and/or the development and maintenance of standards and training programs
- Investigation, problem solving, risk analysis & management, negotiation and influencing skills
- Interest / knowledge of GxP computerized systems used in pharmacovigilance (e.g. QMS, Safety Database, Medical Information)
- Fluent in English
**Travels are to be planned.**
**WHAT WE OFFER**:
- A permanent contract and innovative projects
- An attractive remuneration policy
- Personalized management and continuous learning to develop your career
- Great team spirt and an integration within the "Tribe"
**Job Type**: 100%
Schedule:
- Monday to Friday
Work Location: In person
-
Quality Assurance and Pharmacovigilance Expert
Vor 6 Tagen
Basel, Schweiz ALTOGEN AG Vollzeit**COMPANY** **ALTOGEN** is a Swiss engineering and consulting company specialized in life sciences with expertise in pharmaceuticals, biotechnology, medical devices. With several years of experience, technical expertise and project coordination, we support our partners throughout all areas of the product life cycles. We surround ourselves with junior to...
-
Quality Assurance and Pharmacovigilance Expert
Vor 5 Tagen
Basel, Basel-Stadt, Schweiz ALTOGEN AG VollzeitCOMPANYALTOGEN is a Swiss engineering and consulting company specialized in life sciences with expertise in pharmaceuticals, biotechnology, medical devices.With several years of experience, technical expertise and project coordination, we support our partners throughout all areas of the product life cycles.We surround ourselves with junior to expert level...
-
Quality Assurance and Pharmacovigilance Expert
Vor 5 Tagen
Basel, Basel-Stadt, Schweiz ALTOGEN AG VollzeitCOMPANYALTOGEN is a Swiss engineering and consulting company specialized in life sciences with expertise in pharmaceuticals, biotechnology, medical devices.With several years of experience, technical expertise and project coordination, we support our partners throughout all areas of the product life cycles.We surround ourselves with junior to expert level...
-
Pvqa (Pharmacovigilance and Quality Assurance)
vor 2 Wochen
Basel, Schweiz CTC Resourcing Solutions Vollzeit**The Life Science Career Network** Our client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, committed into delivering products on the market over the next 5 years, is looking a: **PVQA (Pharmacovigilance and Quality Assurance) Manager** for a 12 months-contract based in the area of...
-
Quality Assurance Expert
vor 4 Wochen
Basel, Schweiz ARIAD VollzeitAt Takeda, Quality has always been a priority for us, throughout our long history. Today, what we do in Global Quality touches every part of our diverse organization. It’s reflected in our end-to-end Quality Management System that encompasses R&D, Manufacturing & Distribution, Commercial, Vaccines and our BioLife Plasma collection network. When you’re a...
-
Quality Assurance Expert
vor 4 Wochen
Basel, Schweiz Takeda Pharmaceutical Vollzeit**About the role**: This position is within the Quality organization at the Neuchâtel facility and is intended for the Quality Assurance department. Within this position, QA Expert is responsible for Quality Assurance in the frame of activities all along the manufacturing and release process. **How you will contribute**: QA Expert: - Act as QA(Quality...
-
Quality Assurance Expert
Vor 5 Tagen
Basel, Basel-Stadt, Schweiz ARIAD VollzeitAt Takeda, Quality has always been a priority for us, throughout our long history. Today, what we do in Global Quality touches every part of our diverse organization. It's reflected in our end-to-end Quality Management System that encompasses R&D, Manufacturing & Distribution, Commercial, Vaccines and our BioLife Plasma collection network. When you're a part...
-
Quality Assurance Expert 80-100%
Vor 5 Tagen
Basel, Basel-Stadt, Schweiz Panda VollzeitQuality Assurance expert 80-100% (M/F/d)(Switzerland): Fulltime PermanentMain activities and responsibilities: We are looking for an experienced quality assurance specialist for our Quality Assurance Team at the Basel production site. In this exciting role, you will report directly to the Head of Quality Assurance.Your tasks include: Ensuring compliance with...
-
Quality Assurance Expert
Vor 5 Tagen
Basel, Basel-Stadt, Schweiz ARIAD VollzeitAt Takeda, Quality has always been a priority for us, throughout our long history. Today, what we do in Global Quality touches every part of our diverse organization. It's reflected in our end-to-end Quality Management System that encompasses R&D, Manufacturing & Distribution, Commercial, Vaccines and our BioLife Plasma collection network. When you're a part...
-
DevOps and Quality Assurance
vor 2 Wochen
Basel, Schweiz Optravis LLC VollzeitJOIN OUR DYNAMIC TEAM DevOps and Quality Assurance We are looking for an enthusiastic DevOps to join our growing operations team which ensures high availability and quality of Optravis’ SaaS offering. It’s a rich position that has touch points with development, data analysis and quality assurance. It gives you the opportunity to learn a lot about the...
-
Quality Assurance Expert 80-100%
vor 3 Wochen
Basel, Schweiz Panda Vollzeit**Quality Assurance expert 80-100% (M/F/d)** **(Switzerland)**: - 01.07.2023 - Full-time - Permanent **Main activities and responsibilities**: We are looking for an experienced quality assurance specialist for our Quality Assurance Team at the Basel production site. In this exciting role, you will report directly to the Head of Quality Assurance. Your...
-
Pharmacovigilance Manager
vor 1 Woche
Basel, Schweiz CSL Behring VollzeitAt this position, you are part of the Regulatory Affairs and Pharmacovigilance Team within the Medical Department of the Swiss affiliate at CSL Vifor (no direct reports). You are the main responsible person for independently processing drug safety reports for our products. You perform your tasks in collaboration with other colleagues of the same team as well...
-
Quality Assurance Expert
vor 2 Wochen
Basel, Schweiz Takeda Pharmaceutical Vollzeit**About the role**: **The opening for a Quality Assurance Expert at our Neuchâtel facility offers an engaging role within our Quality department. This position focuses on ensuringexemplary Quality Assurance throughout the various stages of manufacturing and product release.**: - Act as QA representative for both routine GMP activities and Takeda...
-
Quality Assurance Expert
vor 3 Wochen
Basel, Schweiz ARIAD VollzeitAt Takeda, Quality has always been a priority for us, throughout our long history. Today, what we do in Global Quality touches every part of our diverse organization. It’s reflected in our end-to-end Quality Management System that encompasses R&D, Manufacturing & Distribution, Commercial, Vaccines and our BioLife Plasma collection network. When you’re a...
-
Quality Assurance Expert
vor 3 Wochen
Basel, Schweiz ARIAD VollzeitAt Takeda, Quality has always been a priority for us, throughout our long history. Today, what we do in Global Quality touches every part of our diverse organization. It’s reflected in our end-to-end Quality Management System that encompasses R&D, Manufacturing & Distribution, Commercial, Vaccines and our BioLife Plasma collection network. When you’re a...
-
Quality Assurance Manage
Vor 5 Tagen
Basel, Basel-Stadt, Schweiz Coopers Group AG VollzeitQuality Assurance ManagerYou will support and oversee the end to end cGMP activities in implementation of Annex 1 requirements at the Clinical Supply Centre Basel, take care that the Right to Operate can be maintained by ensuring that quality and compliance requirements according to Health Authority expectations and Company Standards for IMP products are...
-
Raqa (Regulatory Affairs and Quality Assurance)
vor 3 Wochen
Basel, Schweiz Indivi Vollzeit**Your mission**: We are committed to transforming healthcare and clinical research by harnessing the power of Digital Biomarker technology. Specializing in the development of innovative software as medical devices, we strive to revolutionize patient outcomes and elevate the standard of healthcare delivery. As our RAQA (Regulatory Affairs and Quality...
-
Quality Assurance Manager
vor 2 Monaten
Basel, Schweiz Lonza VollzeitSwitzerland, Basel**Quality Assurance Manager** **Location: Basle/Switzerland** **Fixed Term Contract - End Date December 2025** Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together,...
-
Quality Assurance Manager
vor 15 Stunden
Basel, Schweiz Lonza VollzeitSwitzerland, Basel**Quality Assurance Manager** **Location: Basle/Switzerland** **Fixed Term Contract - End Date December 2025** Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together,...
-
Head of Process Quality Assurance
vor 2 Wochen
Basel, Schweiz Panda International Vollzeit**Head of Process Quality Assurance**: **Location** - Basel, Switzerland **Job ref** - 22292 **Published** - 1 day ago Our client, a leading company providing active ingredients to the pharmaceutical industry, is seeking a highly skilled and experienced Chemist to join their team as the Head of Process Quality Assurance. **Key Responsibilities**: -...