Pvqa (Pharmacovigilance and Quality Assurance)
vor 2 Wochen
**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 **Basel**.
**Main Responsibilities**:
- Providing expertise and supporting Pharmacovigilance unit;
- Representing PVQA for Pharmacovigilance System;
- Supporting the company, the suppliers and 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);
- Qualifying PV vendors;
- Completing PSMF part under responsibility of PVQA;
- Escalating serious or continuing non-compliance PV issues as appropriate/necessary;
- Providing support with trainings on PV requirements;
- Contributing to PV process improvements (e.g. via audit finding / CAPA) and PV electronic systems (e.g. Testing Quality Event Module);
- Managing PV deviation as per Deviation QS documents;
- Facilitating the PV inspections and CAPAs elaboration, approval and follow-up PVQA Audit;
- Planning, performing, and reporting standards GVP audits (e.g. affiliate, supplier, process, studies).
**Qualifications and Experience**:
- Relevant Swiss working/residency permit and/or Swiss/EU-Citizenship required;
- At least a bachelor degree or equivalent education/degree in sciences or healthcare;
- At least 3 years of experience within pharmaceutical industry/health authorities;
- Good knowledge of GVP regulatory requirements and pharmaceutical industry practices;
- At least 1 year experience in Quality Assurance (QA) within the GxP environment;
- Experience in GxP quality systems, compliance monitoring, CAPA management, and/or the development and maintenance of standards and training programs;
- Being an Auditor.
-
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 2 Wochen
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...
-
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...
-
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 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...
-
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**: -...
-
Quality Assurance Manager
vor 3 Wochen
Basel, Schweiz Panda International VollzeitSenior Quality Assurance Manager Biotechnology 80 - 100% Our client is a leading biotechnology scale-up that is experiencing significant growth and is actively seeking to expand their Quality Assurance division with a permanent position in their department. They are at the forefront of scientific innovation and are dedicated to developing groundbreaking...
-
Raqa (Regulatory Affairs and Quality Assurance)
Vor 5 Tagen
Basel, Basel-Stadt, Schweiz Indivi VollzeitYour 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 Assurance)...
-
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...
-
Director Regulatory Affairs, Quality Assurance and
vor 4 Wochen
Basel, Schweiz BeiGene VollzeitGeneral Description: Under the direction of the General Manager Sub Region Europe, this individual is responsible for the local representation of regulatory affairs and quality assurance in SRE. The incumbent provides dynamic leadership, strategic direction and close oversight of all regulatory affairs and compliance activities in SRE across BeiGene's...
-
Quality Assurance Director
vor 3 Wochen
Basel, Schweiz LHH VollzeitOur client is a Medical Device Company Your next Responsibilities: - To be the Quality Management representative for the site as well as the Person Responsible for Regulatory Compliance - Establishes and maintains quality assurance programs, procedures and controls including quality control, quality engineering, product release, CAPA and non-conformances,...
-
Basel, Basel-Stadt, Schweiz BeiGene VollzeitGeneral Description:Under the direction of the General Manager Sub Region Europe, this individual is responsible for the local representation of regulatory affairs and quality assurance in SRE. The incumbent provides dynamic leadership, strategic direction and close oversight of all regulatory affairs and compliance activities in SRE across BeiGene's...
-
Quality Assurance Manage
vor 2 Monaten
Basel, Schweiz Coopers Group AG Vollzeit**Quality Assurance Manager** You 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...
-
Quality Assurance Manage
vor 15 Stunden
Basel, Schweiz Coopers Group AG Vollzeit**Quality Assurance Manager** You 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...
-
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...