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- Competent and experienced senior auditor for GCP and PV (related to clinical studies).
- Support the implementation of the global quality management system.
- Acts as an ambassador to protect the rights and wellbeing of all participants in drug development activities on behalf of the company.
- To understand and apply appropriate guidelines and regulations, including ICH, FDA, MHRA and EMA and other worldwide regulations, in a risk-based manner to Clinical Studies/Trials, including Pharmacovigilance activities and quality vendor management.
- CQA Quality Lead for Clinical Quality Assurance to support Study teams, providing quality support and regulatory requirements advice/guidance for multiple clinical studies/trials.
- Create and Manage Study Quality Oversight and Audit Plans.
- Conduct Study Quality Reviews and assess/verify GCP Statements.
- To assist with the preparation for GCP/GPvP inspection readiness and supporting inspections by national and international regulatory bodies at Jazz and Investigator Sites
- To report quality issues or non-compliance to the Associate Director CQA and client groups, where appropriate, that are detected whilst carrying out duties for GCP, and other relevant GxP activities.
- To review and assess quality issues or non-compliances and associated corrective and preventative actions to ensure the investigation and actions implemented were appropriate and risk-based in accordance with applicable guidelines and regulations, including ICH, FDA, MHRA, EMA and other worldwide regulations.
- To assist the Associate Director CQA with the promotion of quality awareness among Jazz, vendors and investigator site personnel.
- Typically, 5+ years relevant work experience in the Pharmaceutical, Biotechnology or a related industry
- Demonstrable QA compliance experience and an understanding of applicable GCP regulations and guidelines and some working knowledge of pharmacovigilance regulations and guidelines
- Demonstratable knowledge and experience in audit principles, procedures and techniques
- 3+ years' experience in GCP auditing.
- Knowledge and experience of working to pharmaceutical regulatory standards in clinical research.
- Working knowledge of office IT packages
- Good level of written and verbal communication skills
- Good organisational skills, with the ability to multi-task, including the ability to work independently or as part of a team, to agreed deadlines
- Positive thinking and excellent attention to detail
- Excellent investigative/analytical skills
- Understands risk within clinical trials and is able to apply a risk-based approach to both clinical studies and CQA activities
- Understands and can demonstrate the principles of quality by design in relation to clinical trials
- Customer Focus: Is dedicated to meeting the expectations and requirements of internal and external customers; gets first-hand customer information and uses it for improvements.
- Integrity and Trust: Is widely trusted; is seen as a direct, truthful individual; can present the unvarnished truth in an appropriate and helpful manner; doesn't misrepresent him/herself for personal gain.
- Peer Relationships: Can quickly find common ground and solve problems for the good of all; can solve problems with peers with the minimum of noise; is seen as a team player and is cooperative.
- Functional/Technical skills: Has the functional and technical knowledge and skills to do the job at a high level of accomplishment.
- Action Orientation: Enjoys working hard; is action orientated, full of energy for things he/she sees as challenging; not fearful of acting with a minimum of planning; seizes more opportunities that others.
- Technical Learning: Picks up on technical things quickly; can learn new skills and knowledge; is good at learning new industry, company, product or technical knowledge; does well in technical courses and seminars.
- Timely Decision Making: Makes decisions in a timely manner, sometimes with incomplete information and under tight deadlines and pressure; able to make a quick decision.
- Presentation Skills: Is effective in a variety of formal presentation settings: one-on-one, small and large groups, with peers, direct reports, and bosses; is effective both inside and outside the organisation.
- Problem Solving: Uses rigorous logic and methods to solve difficult problems with effective solutions; probes all fruitful sources for answers; can see hidden problems; is excellent at honest analysis; looks beyond the obvious and doesn't stop at the first answers.
- Self-development: Is personally committed and actively works to continuously improve him/herself; understands that different situation and levels may call for different skills and approaches; works to deploy strengths; works on compensating for weakness and limits.
- Bachelor's degree in science or related discipline
- Post-graduate qualifications (Master's, PhD) preferred
- Trained and competent Lead Auditor (ISO9001 or equivalent)
Senior Clinical Quality Assurance Specialist - Oxford, United Kingdom - Jazz Pharmaceuticals
Description
Brief Description:
Prepare, perform, report and follow-up independent clinical quality assurance audits including associated quality management activities and provide input into the audit schedule. Acts as Lead auditor as applicable. To support Clinical Quality Assurance in its application and development of the Quality Management System and provide expert regulatory guidance and quality support to functional departments involved in all aspects of clinical trials.
Essential Functions/Responsibilities
Required Knowledge, Skills, and Abilities
Skills:
Attributes and Behaviours:
Proven organisational and interpersonal skills, demonstrated through the following competencies:
Required/Preferred Education and Licenses
Knowledge: