As the world's leading pharmaceutical company in the field of dermatology, Galderma, with over 5,500 employees, focuses on the research, production and distribution of innovative medical solutions to meet the dermatological needs of people throughout their lifetime. The Galderma product portfolio is developed to treat various conditions of hair, skin and nails and is available in over 80 countries worldwide.
For our office in Zurich- Switzerland we are currently looking for a
Responsible Person (FvP) and Quality Assurance Manager
Deputy LSO (Local Safety Officer) (m/w)
In this challenging and dynamic role, you will report to the QA Manager Germany/CH. As Responsible person you will overtake responsibilities that are subject to the GMP/GDP regulation. You will be responsible for the release of Galderma products in accordance with regulatory, GDP and other QA requirements, and lead the implementation and maintenance of the quality management system. In addition, you will act as deputy LSO and PV case manager during the absence of the LSO.
Accountabilities:
Responsible Person (FvP):
Responsible for direct supervision of the company concerning all activities covered by the Swissmedic Establishment license
Responsible for compliance with GDP guidelines defined for regulatory purposes (AMBV, GDP guidelines (2013/C 343/01)
Responsible for the implementation and maintenance of a suitable Quality Management System
Responsible for import into Switzerland and export to the destination country
Responsible to ensure a quality system is in place to minimize complaints and timely treatment of batch recalls
Ensure change control and release of changes
Ensure quality risk management, validation and qualification of resources and computerized system
Decision of release or non-release of incoming batches independently from the executive board
Decision of batch recalls and information of the executive board accordingly
You will act as main contact with authorities
Conducting inspections and audits (Swissmedic inspections, internal audits, supplier audits)
Quality Assurance Manager:
Handling of product complaints
Handling of deviations
Development, periodic review, revision and implementation of SOPs as required
Annual product reviews
Organisation and implementation of self-inspections
Review quality agreements with manufacturers, wholesalers and distributors
Overseeing the maintenance and renewals of license (Betriebsbewilligung)
Periodic GxP training for relevant staff
Deputy LSO (Local Safety Officer) and PV Case Manger
You will act as deputy LSO and PV case manager under supervision of the LSO during his absence
Eensure pharmacovigilance case management as per GALDERMA procedures and local laws
Ensures quality control of data and compliance monitoring of timelines and key performance indicators
Reconciliation between local vigilance and corporate vigilance database, local product quality complaints (PQR) and medical information (MI)
Weekly literature monitoring
Your Profil:
Preferable certified Pharmacist, medical doctor or scientific degree, or pharmaceutical professional (min. Master level)
Min. 5 years’ experience in quality assurance; experience as deputy responsible person is required. Thorough technical and GDP knowledge.
Experience in pharmacovigilance, experience in cosmeto- and/or materiovigilance is an advantage
Very good organization, time management and project management skills
Solid communication skills and customer focused approach
Independent and solution-oriented approach
Committed team player
Languages: Fluent English and German required, good French knowledge, Italian is an advantage
Location: Zurich
Looking forward to your application!