Permanent position available to join our Phase I Clinical Research Unit in Leeds, England, as a QA/Regulatory Specialist. This is a unique opportunity to gain experience within the European Phase I Centre for Excellence and allow you to continue to develop your auditing expertise.
COVANCE is a leading global drug development services company providing support to the Pharmaceutical and Biotechnology industries. At Covance, we help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career. This is your chance to become part of a team that helps to bring miracle of medicine to market sooner.
About the Role
As a QA/Regulatory Specialist you would be responsible for hosting client audits and interacting with Health Authority inspectors to represent the company. You will utilise your quality assurance knowledge, experience, skills and training to provide a high standard of audits.
Your duties and responsibilities will include but not be restricted to:
- Coordinates preparations for, and participates in regulatory inspections when requested.
- Act as an expert on broad based routine (day-to-day) regulatory compliance issues, and provide guidance to teams in areas of regulatory compliance.
- Interprets GCPs, applicable GLPs, and cGMPs and associated regulatory documents to facilitate auditing and process improvement recommendations.
- Audits protocols, phases of clinical studies, reports, and performs related duties (e.g. schedules studied/inspections, issues QA statements) to ensure regulatory compliance.
- Audits all disciplines (examples of disciplines include Screening, Recruiting, Clinical Operations, Data Services, IRB, Archives, Vendor and Facility Audits).
- Writes and issues inspection reports. Works with internal customers to ensure that inspection findings are clearly communicated and understood. Evaluates inspection-finding responses to ensure they are written to address the findings appropriately.
- Ensures through process and data inspections that the SOPs, which are involved in the conduct of a study, are current and practiced.
- Identifies and communicates opportunities for process improvement based on audit and inspection observations. Participates in and guides process improvement activities in both small intradepartmental group as well as complex and possible multi-departmental interactions.
- Recommends modifications in procedures to fit special needs or problems and involves supervisor when assistance in process improvement/resolution is necessary.
We Offer the opportunity to work within an experienced and highly skilled team and together with Covance’s ongoing success offer you the prospect of unsurpassed growth and career development opportunities.
Covance offers a comprehensive benefits package including:
- Competitive salary
- Life Assurance
- Health Insurance
- Other voluntary opt-in benefits including Dental insurance, health screenings and many others
Get ready to redefine what’s possible and discover your extraordinary potential at Covance. Here, you’ll have the opportunity to personally advance healthcare and make a difference in peoples’ lives with your bold ideas and unique point of view. With the support of exceptional people from across the globe and an energized purpose, you’ll be empowered to own your career journey with mentoring, training and personalized development planning. Join us as we speed the delivery of ground breaking therapies and anticipate tomorrow’s drug development challenges, creating new possibilities for our clients – and your career.
- EU: Educated to Degree level, or equivalent in a scientific or nursing discipline or equivalent industry experience.
- Demonstrated competencies in quality assurance practices and regulatory compliance knowledge.
- Proficient in use of computer and Microsoft software programs (e.g. Word and Excel).
- Ability to effectively interact with Clinical Pharmacology, CDARO, and ECD management and scientific staff.
- Ability to independently negotiate, provide constructive feedback, and support process improvement initiatives.
- Skilled in both verbal and written communication to effectively communicate and negotiate.
- Recent and relevant experience in the pharmaceutical/CRO industries, including Clinical Quality Assurance, preferably within a GCP environment.
- Additional experience may be substituted for education requirements.
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