GCP Quality Assurance Specialist - Clinical Trials

Want to raise the standards in scientific research? As GCP QA Auditor you’ll have the freedom to take it to the next level.

GCP QA Auditor

UK Based 

Competitive Salary & Excellent Benefits Package including Hybrid Working, Bonus,  10% Pension Contribution, 25 Days Holiday plus Bank Holidays, Private Healthcare Cover, Lifeworks Discounts, ShareSave Scheme and more!

The purpose of this role is to ensure quality, compliance and adherence of Reckitt clinical studies with applicable regulations, standards and guidance including Good Clinical Practice (GCP) as well as maintaining the quality assurance processes supporting clinical studies, primarily performed by the Evidence Generation and Clinical Research (EG&CR) group within Reckitt Health category, and their contracted vendors. You'll:

• Ensure the clinical quality assurance system is established, implemented, maintained and monitored in accordance with applicable regulations/guidance/standards
• Support the implementation and maintenance of the clinical quality management system, in accordance with applicable regulations/guidance/standard as well as business requirements. 
• Assist in the investigation, root cause analysis and CAPA implementation of deviations/non-compliances occurring on clinical studies
• Assist in the assessment and approval of GCP quality management system documentation
• Complete risk assessments and providing input into vendor management/oversight/assurance activities
• Provide quality compliance checks across documentation produced for clinical studies as required (including Protocols, Product Specification Files and Study Release Files)
• Proactively monitor and respond to changes in guidance and legislation issued by Regulatory Authorities related to clinical trials and GCP requirements.
• Contribute to or conduct quality/process improvement initiatives in collaboration with cross-functional partners
• Preparing and presenting review of the company’s clinical QMS to ensure its continued suitability, adequacy and effectiveness in conducting clinical trials
• Actively involved in the preparation for and the management of inspections by regulatory authorities (e.g. MHRA), Notified Bodies etc.

 
You’ll succeed because…

You'll be scientifically qualified and familiar with the research or product lifecycle, you’ve a background in quality and / or audit within healthcare or consumer goods. You’ve a broad knowledge of international regulatory requirements. You’re results-orientated, entrepreneurial and self-motivated. With solid planning and organizational capabilities and the capability to define, evaluate and take risks. You'll have:

• Bachelors degree required (scientific is desirable) 
• Experience in at least one of the following areas is required (Good Clinical Practice, Clinical Operations Activities, Quality Assurance) with experience in all areas being desirable 
• Commitment to quality
• Excellent attention to detail 
• Excellent listening skills, and written and verbal communication skills
• Strong relationship-building and partnering skills
• Strong ability to influence 
• Problem-solving and critical thinking
• Desire to become an auditor

You’ll love it because…

…you’ll have the freedom to make a difference. You’ll put your own ideas into practice. The products you get out there will allow people to live healthier lives and have happier homes. And our dynamic, ownership-driven culture will bring the very best out of you, every day.

Equality

At Reckitt, we recognise that in real life, great people don’t always ‘tick all the boxes’. That’s why we hire for potential as well as experience. Even if you don’t meet every point on the job description, if this role and our company feels like a good fit for you, we still want to hear from you. Come and join a team whose purpose is to protect, heal and nurture in the relentless pursuit of a cleaner and healthier world.

All qualified applicants to Reckitt will receive consideration for employment without regard to age, disability or medical condition; colour, ethnicity, race, citizenship, and national origin; religion, faith; pregnancy, family status and caring responsibilities; sexual orientation; sex, gender identity, gender expression, and transgender identity; protected veteran status; size or any other basis protected by appropriate law.