ASTELLAS PHARMA EUROPE Salary
300 DASHWOOD LANG ROAD BOURNE BUSINESS PARK ADDLESTONE KT15 2NX UNITED KINGDOM
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Earnings on positions in ASTELLAS PHARMA EUROPE
ASTELLAS PHARMA EUROPE is looking for employees for positions:
quality assurance manager
Language
- english
Requirements
- advanced degree in related disciplines
- previous experience in managing staff
- experience in these disciplines in the pharmaceutical industry
- regulated computerized systems auditing experience in a pharmaceutical manufacturing or clinical development environment required
- ability to represent the company to external stakeholders during vendor audits and interacting with regulatory agencies
- experience in developing and maintaining effective relationships with internal and external stakeholders for process improvement and issue resolution project teams
- collaborative skills to facilitate, manage, and work within project teams across departments and global organizations
- in-depth knowledge of GxP regulations and computerized systems in GxP regulated environments, preferably for pharmaceuticals, relating to product development, combined with broad knowledge of quality principals and industry trends
Responsibility
- report status of validation projects to management
- assist TDQA management to plan and manage internal and external resources to execute the TDQA validation oversight and audit programs
- manage programs and resources necessary to support assigned projects
- manage, coordinate, plan, and administrate the TDQA program to oversee the computerized systems validation program and ensure reviews of computerized system validation documentation is completed to ensure compliance with Astellas policies and procedures
- interacts with functional teams to assist QA management to identify QA activities and resources necessary for review and support of project related initiatives
- identify, develop, facilitate, and manage process improvement initiatives that relate to electronic system development life cycles, validation processes, IT systems/processes, data integrity control processes, and regulatory compliance assurance processes throughout Astellas
- serve as QA representative on assigned project teams associated with software validation projects and process improvement initiatives to provide guidance, direction, and support regarding quality assurance and regulatory compliance, to resolve compliance issues, report to management, and to ensure completion of quality related action items
- ensure and facilitate compliance with global Electronic Records / Electronic signatures regulations and provide quality and compliance guidance in areas of continuous improvement, innovation, and validation
Education
- bachelor of Arts/ Bachelor of Science degree, or equivalent