QA Auditor II - III, GCP, Remote, Some EMEA locations
Thermo Fisher Scientific
Bucharest-Bucharest RO West Gate Park RO, RO
‎în urmă cu 19 ore

PPD clinical research services’ mission is to improve health (https : / / www.ppdi.com / about / purpose-mission-strategy).

It starts as an idea to cure. It becomes a life saved. All in-between, it’s you! We know that meaningful results not only require the right approach, but also the right people.

We invite you to re-imagine health promoting protocols with us, working alongside our talented, bright and energetic teams (https : / / www.

ppdi.com / careers / about / culture). Envision a workplace where you have a direct impact on improving health, work alongside expert scientists, use newest technologies and collaborate with industry thought leaders and therapeutic experts.

Our colleagues in quality strive for excellence in every task, at every moment. We are game changers seeking improvements to processes and more efficient ways of working or adapting to changing financial and industry environments.

As a QA Auditor, you will conduct complex internal and external audits and inspections to ensure compliance with established quality assurance processes, standards, global regulatory guidelines and client contractual obligations.

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and well being of our employees.

  • Summarized Purpose : * Conducts complex internal and / or external audits and inspections to ensure compliance with established quality assurance processes, standards, global regulatory guidelines and / or client contractual obligations.
  • Identifies issues impacting the quality and / or integrity of clinical research programs, determines root cause of non-conformance and develops strategies to address issues.

    May perform technical document review and other GxP practice activities in support of clinical development programs. Provides audit reports to management.

    Plans and delivers quality services for contracted quality assurance audits, internal site audits, laboratory and file audits for clients and projects.

  • Essential Functions : * * Conducts and / or leads a variety of client, internal or GxP audits and regulatory inspections as requested by senior management* Leads directed site audits, facility, vendor and / or sub-contractor audits * Provides GxP consultation and support to PPD project teams and external clients Leads process audits and may participate as a co-auditor in more complex system audit.
  • Performs other types of QA audits or activities (e.g. database audits, clinical study report audits, sample results tables, process improvement) * Serves as a resource to operational departments on audit or quality assurance subject matter * Prepares and presents audit findings and / or other related information at departmental, internal operations or client meetings * Provides mentorship and guidance to junior auditors.
  • Education and Experience : * * Bachelor's degree in a life science field or equivalent qualification and relevant experience* Auditing experience in clinical research in regulatory phase trials with high level of competency
  • or Equivalent combination of education and prior directly related experience.*Knowledge, Skills and Abilities : * * Familiar with ICH-Good Clinical Practices and appropriate regional clinical research regulations (e.
  • g., relevant EU Regulations / Directives, EMA and other regulatory agency guidelines)* Internal candidates must have a thorough working knowledge of PPD Clinical Standard Operating Procedures and Working Practice Documents

  • Excellent oral and written communication skills (including appropriate use of medical and scientific terminology)* Strong attention to detail* Able to work independently or in a team environment* Good problem-solving abilities* Good organizational and time management skills* Basic computer skills and ability to learn and become proficient with appropriate applications* Proven flexibility and adaptability* Valid driver's license and ability to qualify for and maintain a corporate credit card with sufficient credit line for extensive business travel.
  • The role will be offered at a level commensurate with the experience of the candidate.*What we offer : *At PPD clinical research services we hire the best, develop ourselves and each other, and recognise the power of being one team.
  • We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD clinical research services you will benefit from an award-winning learning and development programme (https : / / www.

    ppdi.com / careers / about#Training), ensuring you reach your potential. As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees.

    We have a flexible working culture (https : / / www.ppdi.com / careers / life-at-ppd), where PPD clinical research services truly value a work-life balance.

    We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together.

    We are a global organisation but with a local feel. *Our 4i Values : Integrity Innovation Intensity Involvement *If you resonate with our 4i values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, submit your application *we’d love to hear from you!*

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