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Quality Advisor - Operations

Plats Durham, North Carolina, USA Jobb-id R-101651 Datum inlagd 03/02/2021

At AstraZeneca, we work together across global boundaries to make an impact and find answers to challenges. We do this with the utmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s outstanding skills with those of people from all over the globe.

In this role as Senior Quality Advisor, you will support the Quality Assurance organization with compliance and ongoing conformance to established quality assurance processes and procedures for developing inhalation products.

Main Responsibilities:

  • Supports projects to demonstrate process consistency, facility. equipment and cGMP compliance to FDA and EMA regulations and ICH guidelines. Reviews and approves associated protocols and reports.
  • Support application of risk-based analysis to assess and prioritize the requirements for validation.
  • Applies quality standards, policies, procedures, and knowledge of current industry/regulatory standards for validation implementation, execution and completion
  • Represent QA in device validation meetings, discussions and decisions.
  • Maintain internal controls over quality policies and procedures.
  • Assist during Internal/External Inspections.
  • Manage projects related to compliance of the quality system, development of new procedures and controls, and maintenance of established programs.
  • Author or provide quality mentorship in the handling of nonconformance and CAPAs related to the medical device quality systems.
  • Provide quality and technical support for the evaluation of change assessments for combination products and the device quality system.
  • Collaborate with suppliers to address development, risk management, change control, quality or auditing activities.
  • Work cross-functionally to implement product quality requirements and quality standards into design inputs, to develop product specifications, and to conduct design verification and validation activities.
  • Support risk management (e.g. FMEA) and quality planning activities.
  • Support design control gap assessments, remediation planning, and remediation execution as the need arises.

Minimum Requirements:

  • BS in Life Sciences or equivalent.
  • 5+ of experience working in the pharmaceutical and/or biotechnology field with a focus on GMP studies.
  • 3+ of experience in quality assurance preferred
  • Demonstrated knowledge of Quality Assurance activities and ICH and FDA/EU GxP regulations as they relate to clinical trials, product development, manufacturing, and technology transfer.
  • Outstanding interpersonal, problem­ solving, and written/verbal communication skills.

Preferred

  • Excellent team working and networking skills to encourages team effectiveness; ability to lead and inspire colleagues
  • Demonstrates independent judgement and uses risk management in complex situations
  • Capable of making decisions, acting courageously and communicating with conviction and inspiration
  • Demands excellence (sets high bar) and delivers
  • A good communicator with experience of interacting effectively across interfaces collaborating internally
  • Builds excellent relationships both internally and with external suppliers or service providers
  • Demonstrates drive and energy in the role to make a difference

Next Steps – Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.



AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.

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