Aktuelle Jobs im Zusammenhang mit Gxp Auditor - Basel - TFS

TFS HealthScience is excited to be expanding our SRS team and we are looking for an experienced, highly motivated GxP Auditor who shares our vision of providing clinical research excellence. Our SRS team is a highly experienced international group of professionals led by an industry expert.
We are a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. We combine the full-service capabilities and global reach of a large CRO with the flexibility and personal approach only a mid-size CRO can deliver.
Our cores values of Trust, Quality, Flexibility and Passion are what makes TFS Healthscience the successful company it is today. Our values shape our culture and work ethic. They reflect what we stand for and guide our organisation. Together we make a difference.
The purpose of the position is to perform GxP Audits (GMP, GDP, GCP, GVP) and contribute to develop and maintain the global company GxP audit strategy and audit program(s). The audits will be both internal audits/self-inspections within the companys QMS as well as external audits of the companys CMOs, suppliers and service providers. The employee will also have the main responsibility for the administration of audits and audit programs and plannings in the computerised systems at the company.

Key Responsibilities
- Support the strategic development of an effective global risk-based audit strategy (internal & external) and program. Collect, collate, and incorporate input into the audit strategy and plan.
- Plan, lead, conduct, document, and follow-up of GxP audit as Lead Auditor or Co Auditor ( internal audits/self-inspections within the company QMS as well as external audits of the companys CMOs, suppliers and service providers) according to the requirements specified in the respective company procedures (as well as applicable regulations, standards, quality agreements, and guidance documents) working ins strong collaboration with the GxP Audit coordinator and relevant stakeholders.
- Provide regulatory guidance for timely remediation and recommendations regarding acceptability of the proposed filing
- Ensure appropriate escalation to responsible management in case of critical findings and support immediate follow-up. Ensure adequate definition and recording of mitigation plans when applicable.
- Assess the adequacy of responses (CAPA plans) to audit findings in cooperation with the GxP Audit coordinator and other stakeholder QA representative and Auditee.
- Prepare regular status report on performed GxP audits, audit trending and agreed upon metrics to ensure oversight.
- Support Authority inspections and partner audits
- Maintain knowledge of company policies, SOPs, and supporting documents related to drug
- development/manufacturing/distribution as well as FDA and EU regulations and ICH guidance documents (as applicable) along with any other national or international regulations
- SOP Author for SOPs related to GxP audits including supporting documents
- Act as GxP compliance consultant for GxP trainings, task forces, continuous improvement projects as needed.

**Requirements**:

- University degree in Life Sciences or related discipline.
- At least 10 years’ experience from the pharmaceutical industry with GMP/GDP responsibilities.
- Experience of working with GxP audits/inspections.
- Personal attributes
- Excellent knowhow of the EU/US/RoW regulations within GxP
- Excellent verbal and written communication skills
- Excellent knowledge in document handling in computerised systems

**Benefits**:
What can we offer you?
A great place to work where you will get the chance to push your career to the next level, global environment with global opportunities. You will also get the opportunity to be part of a team with highly intelligent, passionate experts from all over the world. TFS HealthScience is a place for inspiration where we focus on the patients, saving lives and aiming to increase their quality of life by supporting our clients.
- Competitive salary & benefits package
- Excellent career progression opportunities
- Great corporate culture and work life balance