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Local GCP/GVP Quality Expert (897139-GB)

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Our client is a pioneer in Drug Discovery and Development and one of the frontrunners in Personalised Healthcare. As the world`s largest R&D spender in the pharmaceutical and diagnostics domain, they work in a vast number of drug discovery & therapeutic areas and are highly recognized internationally. A leader in the field of both in vitro diagnostics and manufacturing and selling of several innovative drugs. We are currently looking for an enthusiastic Local GCP/GVP Quality Expert to be based in Basel.

As an ideal candidate you should have at least 5 years of experience working in Quality Assurance roles within a bio/pharmaceutical company, strong GCP and GVP knowledge, and audit preparation experience.

Local GCP/GVP Quality Expert (897139-GB)

Main Responsibilities:

  • Leads and manages the strategic and operational performance of the Quality Management System (QMS) at affiliate level, ensuring the successful delivery of the Global Quality Strategy, in alignment with annual Quality Objectives, whilst maintaining oversight and adherence to local regulatory requirements;
  • Promotes a quality culture that ensures the highest standards of Quality and Medical Compliance;
  • Proactively monitors and oversees external regulatory changes affecting affiliate quality and compliance;
  • Leads the Risk Management Process for Medical Compliance at local level to proactively identify, manage and treat risks in order to support the business objectives of the local organization;
  • Drives and enables the overall CAPA Management process at local level;
  • Ensures the implementation of global processes and process improvement initiatives in their affiliate with the necessary local subject matter experts;
  • Ensures the maintenance of the Affiliate Quality Management System (QMS) and its related documents, in alliance with the internal Quality principles;
  • Ensures that the Affiliate QMS Handbook is maintained on an annual basis (annually reviewed) and followed by all relevant personnel;
  • Ensures that an annual GCP/GVP local Quality Plan is developed and monitored with Quality Objectives that are aligned with Global Quality objectives;
  • Drives and coordinates the Affiliate audit and inspection process at the local level and is the single point of contact for Product Development Quality;
  • Ensures that a local training grid is in place for all GCP/GVP roles in the affiliates and that appropriate local training curricular are defined and followed in collaboration with local stakeholders;
  • Owns the local controlled document management process and implements and maintains a local process (where needed) that describes the creation and management of local procedural documents in line with global and local regulatory requirements;
  • Ensure that deviations to GCP/GVP processes are managed in accordance with internal global standards;
  • Ensure that all applicable affiliate stakeholders are trained and know their responsibilities of the Global CAPA processes and their responsibilities as identifiers of potential deviations;
  • Facilitates the root cause analysis and impact assessment.

Qualifications and Experience:

  • Relevant Swiss working/residency permit or Swiss/EU-Citizenship required;
  • Bachelor degree in science or biology related field. Advanced degree and/or certification preferred;
  • Demonstrated knowledge of GCP/GVP regulatory requirements and understanding of Quality Principles related to ISO 9001;
  • More than 5 years of experience in a biopharmaceutical/pharmaceutical company;
  • Experience of Health Authority Inspections and audits is highly desirable;
  • Quality Management experience desired and an understanding of Risk Management;
  • Good stakeholder management and the ability to effectively collaborate across a global organization;
  • Fluency in English a must. Fluency in German highly desirable.

Adresse

CTC Clinical Trial Consulting AG
Mr CTC Resourcing Solutions
Münchensteinerstrasse 41
4052 Basel
+41 61 695 88 66

Site web http://www.ctcresourcing.com

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