Quality Assurance and Pharmacovigilance Expert
vor 20 Stunden
**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
-
Pvqa (Pharmacovigilance and Quality Assurance)
vor 20 Stunden
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...
-
Senior Director, Quality Oversight
vor 17 Stunden
Basel, Basel-Stadt, Schweiz Roche VollzeitAbout YouWe are seeking an experienced leader with a proven track record in Quality Assurance. As the PDQ Quality Assurance Process and Affiliate Global Head, you will be responsible for providing strategic leadership and direction to the global Quality Assurance Process & Affiliate teams.You will need to have:Significant years of experience in the...
-
Basel, Schweiz Veristat VollzeitJob Description: Associate Director Quality Assurance and Compliance The Associate Director, Quality Assurance and Compliance (QAC) - Europe serves as the operational manager to direct, oversee, and manage all European clinical quality assurance (QA) activities, and provides hands on administration and management of Quality Systems and ensures compliance...
-
Pharmacovigilance Leader
vor 1 Tag
Basel, Basel-Stadt, Schweiz Roche VollzeitRole SummaryAs Safety Director at Roche, you will be responsible for delivering knowledge on the safety profiles of our medicines, defining how to manage risks to patients, and coordinating pharmacovigilance system activities. You will work closely with cross-functional teams to integrate safety considerations into drug development and lifecycle management....
-
Global Head, PDQ Quality Assurance Process
vor 16 Stunden
Basel, Schweiz F. Hoffmann-La Roche AG VollzeitGlobal Head, PDQ Quality Assurance Process & Affiliates Candidatar-se locations Basel time type Tempo integral posted on Publicado há 2 dias time left to apply Data de término: 15 de fevereiro de 2025 (Mais de 30 dias restantes para se candidatar) job requisition id 202411-129186 Roche fosters diversity, equity and inclusion, representing the communities...
-
Quality Assurance Lead
vor 17 Stunden
Basel, Basel-Stadt, Schweiz gloor&lang AG VollzeitEnd to End Quality StewardshipOur company is an innovative international biopharmaceutical organization with a strong presence in Basel. Our intense R&D activities have given rise to an exciting pipeline of new promising drugs, many of which have successfully reached commercialization stage. With a robust portfolio of on-market products and an extensive...
-
Global Head, PDQ Quality Assurance Process
Vor 2 Tagen
Basel, Schweiz Roche VollzeitRoche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche,...
-
(Senior) Quality Assurance Manager
Vor 2 Tagen
Basel, Schweiz Teva Pharmaceuticals Vollzeit(Senior) Quality Assurance Manager (m/f/d) and Deputy RP 80% Date: Oct 11, 2024 Location: Basel, Switzerland, 4010 Company: Teva Pharmaceuticals Job Id: 58305 About Mepha and Teva in Switzerland Mepha Pharma AG and Teva Pharma AG are together among the leading pharmaceutical companies in Switzerland. Since 2011, Mepha is part of the internationally...
-
(Senior) Quality Assurance Manager
Vor 2 Tagen
Basel, Schweiz Tevapharm Vollzeit(Senior) Quality Assurance Manager (m/f/d) and Deputy RP 80% Date: Oct 11, 2024 Location: Basel, Switzerland, 4010 Job Id: 58305 Mepha Pharma AG and Teva Pharma AG are among the leading pharmaceutical companies in Switzerland. Since 2011, Mepha is part of the internationally active Teva Group, one of the world's leading suppliers of generics. Mepha and Teva...
-
Inspector Quality Assurance
vor 20 Stunden
Basel, Schweiz Line Up Aviation VollzeitMy client, operating in the aviation industry is looking for a: **Inspector Quality Assurance** Permanent Contract Location: Basel, Switzerland Starting ASAP **Position und Responsibilities** - Work in accordance with applicable procedure DOE, POE, MOE, CAME and other Company Specification - Ensure adequate communication and liaison Company Internally and...
-
Global Head, PDQ Quality Assurance Process
vor 16 Stunden
Basel, Schweiz F. Hoffmann-La Roche Gruppe VollzeitRoche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche,...
-
Quality Assurance Manager
Vor 7 Tagen
Basel, Schweiz Talentify VollzeitWe are currently looking for a Quality Assurance Manager that will be responsible for ensuring the quality and compliance of excipients and other direct materials, managing deviations, and collaborating with various departments to maintain inspection readiness.Tasks & Responsibilities:QA Release of excipients and other direct materials.Evaluation and...
-
Raqa (Regulatory Affairs and Quality Assurance)
vor 20 Stunden
Basel, Schweiz Healios 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...
-
Global Quality Assurance Leader
vor 1 Tag
Basel, Basel-Stadt, Schweiz Roche VollzeitJob DescriptionRoche is a leading research-focused healthcare group with over 100,000 employees across the globe. Our success is built on innovation, curiosity, and diversity.We are seeking an experienced leader to join our team as the PDQ Quality Assurance Process and Affiliate Global Head. This role is accountable to the Roche/Genentech Organization for...
-
Quality Assurance Specialist
Vor 6 Tagen
Basel, Schweiz Hamlyn Williams VollzeitAre you a Quality Assurance Specialist? Do you have experience working in the pharmaceutical industry? Are you looking for a new contract?My client is a large pharmaceutical company in Switzerland and is currently looking for talented QA Specialists who have good experience in drug substance to join an ambitious team. You will be working on a fantastic...
-
Quality Assurance Manager
Vor 7 Tagen
Basel, Schweiz Hengrui Europe Therapeutics AG Vollzeit**Job Title**: Quality Assurance Manager **Reports to**: Global Head of Quality Assurance & Training **Department**: Quality Assurance & Training **Location**: Basel, Switzerland OR New Jersey, USA **Direct reports**: No The Hengrui ex-China organization drives the development and commercialization of the Hengrui innovative medicines portfolio for the...
-
Quality Assurance Manager Position
vor 17 Stunden
Basel, Basel-Stadt, Schweiz Gi Group SA VollzeitWe are seeking a skilled Quality Assurance Manager to join our team at Gi Group SA. As a key member of our organization, you will be responsible for ensuring the highest quality standards in our analytical-pharmaceutical environment.About UsGi Group SA is a reputable company in the pharmaceutical industry, committed to delivering exceptional products and...
-
Quality Assurance Manager
Vor 7 Tagen
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...
-
Quality Assurance Manager
Vor 6 Tagen
Basel, Basel-Stadt, Schweiz Gi Group SA VollzeitAbout Gi Group SAWe are a leading recruitment agency specializing in the pharmaceutical industry. Our team is dedicated to providing top-notch services to our clients, and we're looking for a talented Quality Assurance Manager to join our ranks.Job SummaryThe Quality Assurance Manager will be responsible for ensuring that all quality-related documents meet...
-
Quality Assurance Manager
vor 15 Stunden
Basel, Schweiz Flexsis VollzeitFlexsis is part of the Interiman Group, one of the leading providers of personnel services in Switzerland. Thanks to our solid expertise and the competences within the Interiman Group, we offer tailor-made solutions in personnel consulting.For our client F. Hoffmann - La Roche in Basel, we are looking for a motivated and reliable (m/f/d)Quality Assurance...