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• Homebased Allowance for home-based employees
• Car Allowance
• Flexible working schedule

RFIs:

• Provides input into the quality section of RFI / RFP and quality assessments; maintains a library of questions and robust agreed answers

AUDIT:

• Prepare, conduct and follow up on internal GxP audits
• Prepare, conduct and follow up on vendor audits
• Support and guide operational staff in preparing for customer audits
• Assist with hosting client audits, as appropriate

INSPECTION:

• Assist with supporting and guiding operational staff in preparing for inspections including analyse risks and develop inspection readiness strategy
• Assist with preparation and managing the backroom support team

QUALITY MANAGEMENT SYSTEM:

• Facilitates teams from across the company in generating / updating any QMS Documentation; driving the process to ensure no QMS document expires
• Supports staff from across the company to complete accurate and detailed risk assessments and root cause analysis for all quality events, ensure all are completed on time and documentation is always suitable to share with clients as appropriate
• Assists staff to prepare appropriate and robust CAPA Plans (for Quality Events) and track and managing these through to completion ensuring most CAPA are completed on the due date
• Actively contribute to continuous improvement of the organisation and development of routines to enhance the work at TFS

COMPUTER SYSTEMS VALIDATION:

• Assists with all aspects of CSV for all systems across the company

SUPPORT:

• Provide quality advice and support to internal clients

MISCELLANEOUS:

• Prepares and presents training as appropriate
• Participate in internal meetings as required and liaise with other departments as necessary
• Maintain required knowledge of applicable regulations and company GxP standards and procedures
• Other tasks and activities delegated by the Senior Director Quality Management or Associate Director Quality Operations within scope of experience

• University/college degree or equivalent industry experience
• Awareness of the clinical trials area / pharma industry, including knowledge of GxP regulations
• Two years’ experience in clinical research especially in the CSV field
• Excellent interpersonal skills
• CSV knowledge and experience preferable
• Highly-analytical professional with strong attention to detail
• Pro-active, recognizing and anticipating issues, addressing problems and developing solutions
• Good planning, organisation and problem-solving abilities
• Demonstrated ability to multitask, prioritize, and complete objectives
• Excellent oral and written communication skills
• Fluent in English, both written and verbal
• Advance user of MS Office applications

TFS HealthScience does not discriminate on the basis of race, sex, color, religion, age, national origin, marital status, disability, veteran status, genetic information, sexual orientation, gender identity or any other reason prohibited by law in provision of employment opportunities and benefits.