We are looking for...
....a highly motivated Quality Assurance Manager GCP for our Quality unit .
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)
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 or equivalent an auditor qualification would be an asset
Minimum 10 years of experience in the Pharmaceutical industry and a minimum of 5 years experience in QA GCP
Excellent knowledge of GCP and PV legislation and experience in auditing GCP PV and GLP
Experience 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 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 .
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 addition we have preclinical anti-infective assets in our portfolio. Basilea is listed on the SIX Swiss Exchange (SIX : BSLN).
Required Experience
Manager
Key Skills
Quality Assurance,FDA Regulations,Food Industry,Food Safety Experience,ISO 9001,Quality Systems,Food Processing,Quality Control,Quality Management,QA / QC,Selenium,HACCP
Employment Type: Full-Time
Experience: years
Vacancy: 1
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