Quality Assurance and Pharmacovigilance Expert
vor 5 Monaten
**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 5 Monaten
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...
-
Pvqa (Pharmacovigilance and Quality Assurance)
vor 5 Monaten
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 and Compliance Specialist
Vor 6 Tagen
Basel, Basel-Stadt, Schweiz Teva Pharmaceuticals VollzeitQuality Assurance ManagerMepha Schweiz, a leading pharmaceutical company in Switzerland, is seeking a Senior Quality Assurance Manager to support the Commercial Quality Team. The ideal candidate will ensure GMP&GDP compliance by improving and maintaining the quality management system's processes and documents. They will contribute to audits and inspections,...
-
Quality Assurance Expert
vor 5 Monaten
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 4 Tagen
Basel, Basel-Stadt, Schweiz Gi Group SA VollzeitGi Group SA is seeking a Quality Assurance Manager to join our team in Basel. We are looking for a detail-oriented professional to review and approve SOPs, protocols, reports, and other quality-related documents.Main Responsibilities:Review and approve SOPs, protocols, reports, and Certificate of Analysis;Investigate deviations and out of specifications...
-
Pharmacovigilance Specialist
Vor 7 Tagen
Basel, Basel-Stadt, Schweiz Teva Pharmaceuticals VollzeitAbout Mepha and TevaTeva Pharmaceuticals and Mepha Pharma AG are two leading pharmaceutical companies in Switzerland, working together to bring innovative medicines to patients. As part of the Teva Group, Mepha has a strong presence in the market, with a portfolio of over 320 products used in primary care to treat a wide range of diseases. Our team is...
-
Senior Quality Assurance Manager
Vor 7 Tagen
Basel, Basel-Stadt, Schweiz Teva Pharmaceuticals VollzeitAbout Teva PharmaceuticalsTeva Pharmaceuticals is a leading pharmaceutical company with a strong presence in Switzerland. With a portfolio of over 320 products, we cater to a wide range of diseases across various therapeutic areas. Our commitment to quality and regulatory compliance is unwavering, and we strive to maintain the highest standards in our...
-
Quality Assurance Manager
vor 1 Woche
Basel, Basel-Stadt, Schweiz Teva Pharmaceutical Industries VollzeitJob DescriptionMepha Pharma AG and Teva Pharma AG are leading pharmaceutical companies in Switzerland, combined with the internationally active Teva Group, one of the world's leading suppliers of generics.The companies are based in Basel and employ 174 people in total. The portfolio comprises over 320 products, primarily used in primary care to treat various...
-
Pharmacovigilance Associate
Vor 4 Tagen
Basel, Basel-Stadt, Schweiz Teva Pharmaceuticals VollzeitJob DescriptionMepha Schweiz Ltd is currently seeking a skilled Pharmacovigilance (PV) Associate to support the Head of Pharmacovigilance Switzerland and Local Safety Officer in maintaining the local Pharmacovigilance System. As a Deputy Local Safety Officer, this individual will collaborate closely with the PV cluster, regional, and global Pharmacovigilance...
-
Quality Assurance Manager
vor 2 Monaten
Basel, Basel-Stadt, Schweiz Randstad Professionals VollzeitJob Title: Quality Assurance ManagerWe are seeking a highly skilled Quality Assurance Manager to join our team at Randstad Professionals. As a key member of our organization, you will be responsible for ensuring the quality and compliance of our pharmaceutical products.Key Responsibilities:Support Quality activities in LATAM and MMG operational areas, acting...
-
Senior Quality Assurance Manager
Vor 4 Tagen
Basel, Basel-Stadt, Schweiz Teva Pharmaceuticals VollzeitAbout Teva Pharmaceuticals in Switzerland Teva Pharmaceuticals AG and Mepha Pharma AG are together among the leading pharmaceutical companies in Switzerland. As part of the internationally active Teva Group, one of the world's leading suppliers of generics, Mepha is committed to delivering high-quality products. With a portfolio comprising over 320 products,...
-
Quality Assurance Manager
vor 4 Wochen
Basel, Basel-Stadt, Schweiz Randstad VollzeitJob DescriptionAs a Quality Assurance Manager, you will play a crucial role in ensuring the compliance of our client's pharmaceutical products with GxP regulations. You will be responsible for overseeing the Quality Management System, conducting audits, and providing quality advice to internal and external stakeholders.Key ResponsibilitiesSupport Quality...
-
Quality Assurance Manager
vor 3 Wochen
Basel, Basel-Stadt, Schweiz Randstad VollzeitJob Description:As a Quality Assurance Manager at Randstad, you will be responsible for supporting quality activities in LATAM and MMG operational areas, acting as the Responsible Person for LATAM GmbH and Medical GmbH. You will execute Quality Management system activities on behalf of IACs to ensure compliance with GxP legislation.Key...
-
Basel, Basel-Stadt, Schweiz Randstad VollzeitJob Title: Head of Quality Assurance and Management TechnologyJob Summary:We are seeking an experienced Head of Quality Assurance and Management Technology to oversee the quality assurance and control for hardware and software products. The ideal candidate will be responsible for ensuring compliance with European and international standards, managing quality...
-
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 Associate
vor 4 Wochen
Basel, Basel-Stadt, Schweiz Teva Pharmaceuticals VollzeitAbout Teva PharmaceuticalsTeva Pharmaceuticals is a leading global pharmaceutical company with a strong presence in Switzerland. As a part of the company, Mepha Pharma AG and Teva Pharma AG are among the top pharmaceutical companies in the country. With a portfolio of over 320 products, Teva Pharmaceuticals offers a wide range of medicines for various...
-
Quality Assurance Manager
vor 3 Wochen
Basel, Basel-Stadt, Schweiz Gi Group SA VollzeitJob DescriptionGi Group SA is seeking a highly skilled Quality Assurance Manager to join their team. The ideal candidate will have a strong background in Quality Assurance and experience in implementing Annex 1 requirements in a GMP regulated environment.Key Responsibilities:Support and drive implementation of Annex 1 requirements in the Clinical Supply...
-
Director of Quality Assurance and Compliance
vor 2 Monaten
Basel, Basel-Stadt, Schweiz Acadia Pharmaceuticals Inc. VollzeitJob SummaryWe are seeking a highly experienced and skilled Associate Director Quality Assurance to join our team at Acadia Pharmaceuticals Inc. This is a key leadership role that will be responsible for overseeing the quality assurance function and ensuring compliance with regulatory requirements.Key ResponsibilitiesQuality Assurance Leadership: Provide...
-
Quality Assurance Manager
vor 3 Wochen
Basel, Basel-Stadt, Schweiz Randstad VollzeitJob DescriptionAs a Quality Assurance Manager at Randstad, you will be responsible for supporting quality activities in LATAM and MMG operational areas, acting as the Responsible Person for LATAM GmbH and Medical GmbH. This role requires a strong understanding of GxP legislation and the ability to execute Quality Management system activities on behalf of...
-
Quality Assurance and Regulatory Associate
vor 2 Monaten
Basel, Basel-Stadt, Schweiz Stratpharma AG VollzeitStratpharma AG, a leading pharmaceutical company, is seeking a highly skilled Quality Assurance and Regulatory Associate to join their team. This is an exciting opportunity to work closely with the International Quality Assurance and Regulatory Director in managing the company's global quality assurance and regulatory functions.This is a highly successful...