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QA Reviewer

Job Introduction

Thanks for checking out our vacancy, we’re delighted you want to learn more about Dechra.

Dechra is a growing, global specialist within the world of veterinary pharmaceuticals. Our expertise is in the development, manufacture, marketing and sales of high quality products exclusively for veterinarians worldwide.

Here at Dechra, our values are embedded within our culture and thrive within our family of almost 2000 colleagues globally. From manufacturing to marketing, (D)edication, (E)njoyment, (C)ourage, (H)onesty, (R)elationships and (A)mbition are at the heart of our everyday operations and the way we do business

The Opportunity 

The QA Reviewer is responsible for a variety of Quality activities to ensure compliance with applicable quality objectives and regulatory requirements in the cGMP Quality organization. Reporting to Remediation Lead.

 

Role Responsibility

So, what will you be doing? This role has a broad and varied remit and the successful candidate will have responsibility for duties including:

  • Supports all activities for the Quality Operations and Compliance groups.
  • Work with manufacturing and laboratory management to ensure activities comply with regulatory requirements.
  • Ensure procedures are adequate to review and confirm appropriateness of raw data.
  • Review and approve manufacturing and QC laboratory investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.
  • Ensure appropriate deviations and CAPAs are generated to increase compliance and prevent repeat occurrences of deviations.
  • Supports audit and inspections in various capabilities.
  • Establishes and maintains procedures to ensure data integrity is maintained and procedures/processes are compliant.
  • Review proposed changes to systems, procedures, and methods.
  • Perform quality review of manufacturing and laboratory investigations, GMP and Quality System issues, non-conforming materials, and CAPA, as needed.
  • Must have strong authorship and be able to critically review investigations, interpret results and generate technical conclusions.
  • Must be able to note technical/scientific attributes in potential situations or issues and process science-based solutions across most of the job function.
  • Must be skilled in planning and organizing, decision-making, and building relationships.
  • Able to effectively multi-task.
  • Routinely recognizes Quality issues and solves problems.
  • Follows established procedures and performs work as assigned.
  • Perform other duties as required to fulfil department and business needs.

The Ideal Candidate

Here at Dechra we pride ourselves on being an inclusive employer and we embrace candidates from all walks of life. We’re particularly keen to hear from those who have/are:

  • Preferred experience in Quality and/or Investigation departments.
  • Must have knowledge and experience with cGMP manufacturing, Quality, and Compliance.
  • Thorough knowledge of and competence in quality processes, including but not limited to material disposition, deviations, investigations, and CAPA management.
  • Must have strong authorship and be able to critically review investigations, interpret results and generate technical conclusions.
  • Knowledge of audit and inspection readiness.
  • Must be able to note technical/scientific attributes in potential situations or issues and process science-based solutions across most of the job function.
  • Must be action-oriented and customer-focused, building relationships, problem solving, planning and organizing, resource allocation, and analytical thinking
  • Must possess an independent mindset and tenacity.
  • Ability to interpret results and situations and articulate recommendations for resolution.
  • Capable of providing input within the department and cross functional teams.
  • Contributes to goals within the work group.
  • Able to prepare written communications and communicate problems to management with clarity and accuracy.
  • Able to write and review reports with clarity and brevity.
  • Able to effectively multi-task.
  • Knowledge of US and global cGMP requirements.
  • Teamwork and ability to work effectively across functional groups and teams to ensure requirements are met.
  • Excellent verbal and written communication skills.
  • B.S. Degree

 

About the Company

As a people first values-based culture, we provide free weekly wellness sessions focused on our employee's physical and mental wellbeing, and flexible work arrangements. We offer a generous employer 401k match and competitive salary packages for financial wellness. Our full array of health, financial and voluntary benefit programs are what you would expect from a recognized Best Place to Work.

Dechra Pharmaceuticals PLC

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