Beschreibung
Areas of responsibility:- Responsible for the release of Investigational Clinical Materials (IMP) and related labels and packaging in close cooperation with the QA Dev Manager.
- Supports the implementation and maintenance of the local Quality System in the areas of GCP and GPvP, in accordance with the Companies Quality Manual and the CPO Quality Plan.
- Conduct proactive in-process quality and compliance review through monitoring of adequate Key Quality Indicators (KQIs) and assure that gaps are addressed appropriately in order to mitigate risk.
- Supports vendor assessment and/or qualification visits for locally outsourced clinical development, MA and pharmacovigilance (PV) activities.
- Partner with Pharma Development QA in the preparation, execution and follow-up of audits on clinical development activities. Together with the audites, determine root causes for country-specific major and critical audit. Verify that appropriate corrective and preventive actions are implemented on all major and critical audit findings.
- In cooperation with the local GMP QA Unit ensure analysis, assessment and resolution (including CAPAs where indicated) of issues with common interfaces.
- Participate in PH Dev QA investigation activities, as appropriate.
- Supports CPO readiness for all GxP regulatory inspections.
- Provide support prior to, during and after HA inspections of the CPO, investigational sites or external service providers, as applicable, together with the Company inspection lead. Ensures that responses to local Health Authorities have been submitted, commitments have been met and relevant CAPs have been completed/closed.
- Supports the conduct of adequate training at the CPO for all GCP and GPvP activities.
- Ensure that the clinical and PV computerized systems are adequately identified during the High Level Risk Assessment for GXP relevance to enable their validation where required.
Recruitments:
- Degree in Life Sciences or related fields
- German and English fluent in speaking and writing.
- Min. 1 year experience in the pharmaceutical industry in a relevant field such as quality assurance, quality control, registration, clinical development or a directly related area
More Details:
- 6 Months with theOpportunityfor an Extension
- Location:North Switzerland
- 80% onsite with option of a home office
- Start date: a.s.a.p.
For a confidential discussion about regulatory affairs projects in Switzerland, or to apply, then send your CV to or call me.
I am a specialist recruitment consultant in regulatory affairs for the Pharmaceutical & Biotechnology industry. I offer a number of search options within the industry with a special focus on Switzerland.
If you are a Pharmaceutical professional looking for your next opportunity, then please don't hesitate to get in contact with me. Alternatively if you are currently looking for skilled individuals for the development of your organisation, then I can certainly help.
Your personal contact:
Kristina Bröckel
Regulatory Affairs Consultant
Tel:
mailto:
To find out more about Real please visit www.realstaffing.com