Qualified Person

4 weeks ago

Dublin, Dublin City, Ireland PE Global Full time

6 days ago Be among the first 25 applicants

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Direct message the job poster from PE Global

Recruitment Manager - Contracts at PE Global

PE Global is currently recruiting for a Qualified Person/Responsible Person on behalf of our client based in North Dublin:

Qualified Person/Responsible Person

Duties/Responsibilities

  1. Qualified Person certification and batch release of clinical supplies
  2. Acts as a Responsible Person on a WDA for Pre-Approval Access
  3. Support for Health Authority GMP/GDP inspections and audits across the supply chain
  4. Advise stakeholders on quality issue management and process enhancement/compliance - ensuring consistent quality standards and fostering strong working relationships
  5. Incorporate global regulatory trends and changes into Supply Chain Quality
  6. Manufacturers Authorisation update and maintenance
  7. Ensure rapid communication of quality issues or significant deviations, to business partners and senior management
  8. Review and approve procedural documents
  9. Participate in multidisciplinary or cross-functional work/project teams; serve as part of strategic team(s) within the group/discipline
  10. Provide guidance and expectations to the business to enable execution of external and internal regulations on a global and cross functional level
  11. May influence the external environment through interactions with regulators, trade associations, or professional societies
  12. Proactively identify risk areas
  13. Provide input in the global audit plans based on identified signals/trends/risks/gaps
  14. Undergo continuous professional development including self-study, site visits, internal and external training courses and audits
  15. Support OPEX programs and champion continuous quality improvement initiatives

Skills/Qualifications

  1. A degree in science, engineering or related discipline is essential along with 10 years' experience in a role within the biopharmaceutical/pharmaceutical industry
  2. Must be eligible to act as Qualified Person on the Manufacturing/Importation Authorisation
  3. Previous experience as a Responsible Person on a WDA is preferred
  4. Demonstrated strong knowledge of ICH/GMP, data integrity, regulatory guidelines/directives, clinical supply chain processes and principles of Quality Assurance
  5. Proven track record of building/ maintaining high-performance teams/organizations and influencing/ motivating global teams to achieve results—delivering on business and program goals
  6. Proven leadership / influence management skills with ability to foster partnerships in the matrix organization across functional/ geographic/ cultural/partner boundaries
  7. Proven clear communication supporting delivery for the business
  8. Fosters a culture in which people continually work to improve services, and work processes

Interested candidates should submit an updated CV.

Please click the link below to apply, call Audrey on 0214297900 or alternatively send an up-to-date CV to audrey.mccarthy@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***

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