Quality Assurance and Pharmacovigilance Expert - Basel, Schweiz - ALTOGEN AG

ALTOGEN AG

Geprüftes Unternehmen

Basel, Schweiz

vor 1 Tag

Geschrieben von:

Lena Schneider

beBee Recruiter

Beschreibung

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 noncompliance 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 followup for PVQA manager expected to be also an PVQA Auditor as defined in company's SOP101134:
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 followup 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: