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Job Opportunity

Job Opportunity
Qualified Person (QP)
Qualified Person (QP)
Ireland     Posted 2024-10-25

Qualified Person (QP)

 

The Qualified Person (QP) will fulfill QP duties in relation to release of drug substance manufactured under GMP at WuXi Biologics Ireland, and drug product manufactured at other WuXi Biologics sites, in accordance with the requirements of EC/2001/83, EC2001/20, Annex 16 “Certification by a Qualified Person and Batch Release” and 13 “Investigational Medicinal Products”, as applicable.

 

Organization Description:
WuXi Biologics is a premier provider of biologics services (from discovery to commercialization) with global customers in the biopharmaceutical and healthcare industries. We´re one of the world's top three contract development and manufacturing companies for biopharmaceuticals, we provide our clients with a world-leading open access technology platform. We enable our clients to research, develop and manufacture drugs from the concept phase to commercial manufacturing. Our mission is to accelerate and transform discovery, development, and manufacturing in the rapidly growing field of biologics to benefit patients worldwide. We currently employ over 10,000 people and provide services to more than 200 customers worldwide, including 13 of the top 20 biopharmaceutical companies.

 

Department Description

As Qualified Person (QP), you’ll be joining an organization where people of all backgrounds and experiences are respected, and where we work together focused on changing lives.  In this role you will report to the Senior Qualified Person.

 

Your Responsibilities:

  • Prepare and review SOPs/TRA/SRDs as required.
  • Participate in cross-functional teams and projects, as required.
  • Lead and participate in investigation of product/facility deviations and investigations including root cause analysis. Escalate and/or cascade technical/quality issues to management.
  • Participate in internal GMP audits of manufacturing facilities and systems and work to resolve audit observations as required.
  • Prepare and review QP to QP agreements where applicable.
  • Provide clear, direct, and timely verbal and written communication to stakeholders.
  • Participate and act as an SME in internal audits or host internal audit team & regulatory inspections (e.g. HPRA)
  • Perform all duties in accordance with GMP requirements, SOPs and controlled documents
  • Flexibility to take on additional tasks and responsibilities at the discretion of the QA Director.
  • Will act as a role model for the QA function and also the wider organisation in adherence to the WuXi corporate core values and PROUD culture.

 

 

Person Specification:

 

Required Technical Competencies:

  • Strong technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures).
  • Strong knowledge of cGxP requirements and regulations.
  • Knowledge of trouble shooting and problem solving skills; e.g. formal root cause analysis such as Ishikawa diagrams, FMEA etc.
  • Demonstrated knowledge of Quality Management System and continuous/process improvement tools
  • Demonstrated experience within highly regulated environments e.g. FDA, HPRA and others.

 

Knowledge/Experience:

  • The QP should ideally have a minimum of 3 years’ experience named on an MIA and actively performing QP release.  It is preferable the QP performed release of drug substance or drug product in a sterile or aseptic manufacturing facility.
  • Ideally the candidate should have approximately 8 years’ QA experience in a cGMP regulated manufacturing environment with a thorough understanding of compliance.
  • Understand European and rest of world regulatory requirements, guidelines, and expectations.
  • Be up to date with respect to the current Good Manufacturing Practices (cGMP), technologies and quality systems for the products they certify.
  • Demonstrated knowledge of Quality Management System and continuous/process improvement tools.

 

Qualifications

  • QP Qualification, meeting the requirements as set out in EU Directive 2001/83/EC for Medicinal products for human use.
  • Degree level Qualification in Biopharmaceutical Science or other related science discipline.  

 

Behavioural Competencies

  • Adaptable, able to multi-task and handle tasks with competing priorities effectively to deliver site priorities.
  • Demonstrated collaboration, negotiation & conflict resolution skills with a teamwork mindset.
  • Excellent communication skills (written and oral).
  • Analytical, problem solving & root-cause analysis skills
  • Able to challenge the status quo with a continuous improvement mindset.
  • Ability to interpret technical information related to equipment, process, and regulatory requirements and make key quality decisions.
  • Provide clear, direct and timely verbal and written communication to stakeholders.

 

Onerous Requirements

  • There may be a requirement for occasional travel to locations within Ireland and overseas to support business needs. Must be willing to travel when required.

 

As we extend our global reach, we need colleagues interested in change, in challenge, and in building a new future together. Reach beyond yourself and discover your true potential!

If you have the ability to thrive in a dynamic and fast-paced environment and feel that the moment has come for you to be part of such an exciting journey towards accomplishing our mission - Any drug can be made, and any disease can be treated - don’t miss out on this opportunity to join us and reach beyond yourself and discover your true potential.  Apply now!

 

Would you like to know more before you apply? Please visit us at https://www.wuxibiologicscareers.ie/ or contact us via talentacquisition@wuxibiologics.com

 

 WuXi Biologics is an equal opportunities employer.

Apply now