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Job Details

Principal Auditor (Quality Professional)

Company: Roche
Location: Welwyn
Reference: 201811-128472
Closing Date: 09 Jan 19
Type: Full Time
Salary (£): Competitive
Benefits:

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Job Summary:

Position Title: Principal Auditor (QA Professional)Location: Welwyn Garden City, UK (office or off-campus (home based))Do you believe that Quality Assurance can bring vital products to patients faster? Do you believe that Quality Assurance can be more than simply the conduct of audits?The mission of Roche Product Development Quality is to achieve unrivaled transparency with health authorities so that our medicines are brought to patients safely and quickly. ...

Requirements:

Position Title: Principal Auditor (QA Professional)
Location: Welwyn Garden City, UK (office or off-campus (home based))


Do you believe that Quality Assurance can bring vital products to patients faster? Do you believe that Quality Assurance can be more than simply the conduct of audits?

The mission of Roche Product Development Quality is to achieve unrivaled transparency with health authorities so that our medicines are brought to patients safely and quickly. We instill confidence that our non-clinical, clinical and pharmacovigilance activities comply with regulations and guidelines. We partner with internal functions, process owners and study teams to provide a quality framework that protects patient safety and the company's license to operate.

We are looking for somebody who has the ability to connect systems with process and review data to not only identify a GXP non-compliance, but also determine impact and communicate that impact to our stakeholders who are Business Process Owners, System Owners and Study Teams. You will have strong influencing, critical thinking skills and can apply these in the development, evaluation and communication of quality strategies to our study teams and process owners. Ideally, you are familiar with the use of data analytics, preferably in clinical trials and safety reporting.

Forming part of a highly successful quality assurance team, you can apply your functional expertise in analytics, clinical science, development operations, risk and safety management, and/or regulatory affairs to uncover new ways of promoting and embedding an agile, fit-for-purpose quality management framework. We believe in broadening and deepening the capabilities of our team and invest in cross training across GXPs and Computerized Systems. As part of your responsibilities, you will lead the development of quality strategies and evaluations of priority clinical development programs, with the aim of demonstrating protection of patients and reliability of trial results. You will demonstrate these industry leading strategies in regulatory authority inspections.

Experience it for yourself. Everyday your contribution will positively influence patient outcomes.

Who you are

  • You're someone who wants to influence your own development. You're looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.
  • You are searching for your next challenge in your career, one where you are able to creatively apply your extensive experience in drug development.
  • You're a strong influencer and can negotiate the most complex issues towards effective solutions.
  • To succeed in this role, you are able to display initiative, balance attention to detail with big picture thinking, and you are focused on securing results with determination to solve problems.
  • Your diplomacy and communication skills will also be needed in supporting the business and senior management within a cross functional, international environment.
  • Degree qualified in biomedical, scientific or IT discipline combined with strong industry experience within pharmaceutical or biotech clinical research, you ideally have Quality Assurance auditing experience in GCP/PV and Computer Systems in an international environment but this is not essential.
  • Must be willing to occasionally travel domestically and internationally (20 - 40% travel).


Closing date for applications is Monday 17th December 2018. 

Roche is an equal opportunity employer.
Quality, Quality > Quality Compliance & Audit

Apply for this job: Principal Auditor (Quality Professional)

Contact Information:

Address:  UK Head Office
P.O. Box 8, Welwyn Garden City, Hertfordshire, United Kingdom
AL7 3AY
England
Tel:  +44 1707 36 6000
Fax:  +44 1707 33 8297
Website:  Visit Our Web Site

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