Company: Planet Pharma Staffing Limited
Location: London, UK
Closing Date: 05 Feb 17
Salary (£): On Application
Planet Pharma are looking for an experienced QA Professional / Senior GCP Auditor for an exciting opportunity with an international pharmaceutical company in London! Please get in touch for more details!
Role: Senior Manager, GCP / Senior GCP Auditor – International Pharmaceutical Company
Location: London, UK
Job Type: Permanent
Planet Pharma are recruiting for a Senior Manager, GCP on behalf of our client, an international Pharmaceutical Company in London. The Senior Manager / Senior Auditor is responsible for designing, setting up, maintaining and the execution of robust GCP compliance programmes. This is an exciting opportunity for an experienced QA GCP professional to work for an international pharmaceutical company who are expanding their operations in Europe!
Responsibilities and Duties
- Responsible for designing, setting up, maintaining and the execution of robust GCP compliance programmes for both Local and Global Clinical Trials Audit Programmes, ensuring compliance with regulatory standards, company policies, SOP’s and procedures are fit for the business
- Continuously build and innovate in all aspects of GCP Compliance
- Serve as a subject matter expert by providing high standard of quality guidance, advice and support on GCP compliance
- Partner and support the compliance journey for GCP achieving a “First time right” approach in relevant issues/initiatives
- Managing and performing/handling GCP investigations regarding Quality Issues, Misconduct Investigations including Serious Breaches etc.
- Manage and identify potential systemic compliance risks including Investigations of deviations and monitoring of corrective actions and preventative (CAPA) relating to non-compliance issues and findings
- Provide quality support and contribute to QA process improvement
- Assist in the development and implementation of training strategies and programmes
- Development and enhancement of European Quality Management System
- Write and revise QA Standard Operating Procedures (SOPs)
- Coordination of SOP writing with other Functional Areas
- Providing the Head of QA & Compliance with information on the level of compliance and compliance issues
- Contribute to the development and maintenance of QA tracking and compliance tools
- Establishing and maintaining GCP regulatory inspection readiness; managing and supporting regulatory inspections
- Assuring compliance key performance indicators for GCP are set-up, maintained, performed and reported to detect and monitor any significant compliance deviations to the company quality standards and/or regulatory requirements
- Bachelors degree in a scientific field
- Extensive recent hands-on GCP Auditing experience
- Significant experience in senior compliance role, with responsibility for GCP, ICH and applicable legislation
- Extensive experience in the pharmaceutical industry
- Experience in having worked in a matrix global environment, especially in an outsourced model with CROs/vendors across multiple geographies
- Comprehensive understanding of pharmaceutical regulatory requirements and impact on the various functions within the business
- Ability to identify proactively and anticipate risk of non-compliance in a complex environment
- Ability to develop and manage efficient and effective compliance systems
- Ability to project manage, set clear strategic goals, align priorities and lead multiple tasks/activities within a virtual/remote team
- Initiative with a can-do, flexible attitude and ability to multi-task
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