Overview
Quality Assurance Manager GCP/PV/GLP Jobs in Allschwil, Kanton Basel-Landschaft, Switzerland at Basilea Pharmaceutica
We are looking for…
….a highly motivated Quality Assurance Manager GCP/PV/GLP for our Qualityunit.
Your tasks
Provide QA oversight for GCP/PV/GLP activities within the company and at vendor/investigator sites for assigned studies/ compounds
Act as QA contact person for vendors/investigator sites for related GCP/PV/GLP studies
Support continuous improvement of the Quality Management System (QMS) and related processes, including establish and update QMS documents
Contribute to a risk-based strategy for QA activities (GCP/PV/GLP)
Support continuous improvement of the Quality Management System (QMS) and related processes, including establish and update OMS documents
Ensure timely and appropriate management of non-conformances related to relevant GCP/PV/GLP deviations, quality issues, investigations, CAPAs, and change control
Support inspection readiness of Basilea and Vendors conducting GCP, PV, and GLP activities through review audit findings, CAPA generation and review, and training
Support preparation, conduct and follow up of audits and inspections at client sites and partners as required
Ensure audit results are formally tracked, recorded and reported
Coordinate and lead internal or external training activities
Willingness to travel for audits
Your profile
University degree in pharmacy, chemistry, chemical engineering or equivalent, an auditor qualification would be an asset
Minimum 5 years of experience in the Pharmaceutical industry and a minimum of 3 years’ experience in QA GCPExperience in auditing GCP and GLPExperience in GCP/GVP related Health Authority Inspections (FDA, BfArM) Familiar with writing/reviewing sections of regulatory documents (IMPDs, INDs)
Ability to work both independently and collaboratively, well-organized and structured with excellent technical and analytical skills Excellent communication and presentation skills at different levels
Fluency in English written and spoken is essential, any other language would be beneficial
Why us?
Basilea is committed to putting people first. In addition to competitive remuneration, we offer the opportunity to work on inspiring, cross-functional projects in an engaging working environment. We strongly believe that every employee can make an impact and is vital to our success. If you wish to become part of a company that strives to make a difference to the lives of patients worldwide, we are looking forward to receiving your application.
Additional information can be found on our website .
About us Basilea is a commercial-stage biopharmaceutical company founded in 2000 and headquartered in Switzerland. Basilea has about 150 employees. We are committed to discovering, developing and commercializing innovative drugs to meet the needs of patients with severe bacterial or fungal infections. We have successfully launched two hospital brands, Cresemba for the treatment of invasive fungal infections and Zevtera for the treatment of bacterial infections.
In addition, we have preclinical anti-infective assets in our portfolio. Basilea is listed on the SIX Swiss Exchange (SIX: BSLN).
Title: Quality Assurance Manager GCP/PV/GLP
Company: Basilea Pharmaceutica
Location: Allschwil, Kanton Basel-Landschaft, Switzerland
Category: Quality Assurance – QA/QC, Pharmaceutical
