Quality Assurance Manager GCP
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Job Location:
Arlesheim - Switzerland
Monthly Salary:
Not Disclosed
Posted on:
8 days ago
Vacancies:
1 Vacancy
Job Summary
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 10years 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 .
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
About Company
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 inf ... View more
