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Rachel Kent
Life Science

+353 87 427 8808
[email protected]
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Details

Qualified Person


Reference:RK2820 Location: Dublin
Qualification:DegreeExperience:3-4 Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Qualified Person

Qualified Person
RK2820
12 Months
Dublin



We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.


Duties:

  • Perform activities as required per procedures as QA staff, and in particular where the role of QP is specified in the procedures
  • Own, review and approve SOP’s and other GDP/GMP documentation and records, ensuring that Corporate, Site and Regulatory requirements are met.
  • Perform review and approval of validation documentation.
  • Lead and participate in internal and external audits as needed.
  • Maintain a close contact and familiarity with Quality systems and programs utilized at other sites.
  • Provide guidance and direction to Quality, Production, Warehouse/ Distribution and Supply Chain staff in regard to compliance with quality policies, standards and procedures.
  • Evaluates and assess change control records, nonconformances and CAPAs.
  • Participate in global Quality initiatives as a site subject matter expert.
  • Participate or lead projects and improvement efforts including product launches.
  • Supports the evaluation of quality and distribution complaints.
  • Supports regulatory inspections or various questions from regulatory bodies.


Education and Experience :
  • University Degree in a Science related discipline together with a post graduate course, which together with the primary qualification, satisfies the educational requirements as defined in Directive 2001/83/EC OR University Degree in Pharmacy
  • Knowledge of the processes involved in manufacturing (GMP), warehousing, supply chain, equipment engineering principles and validation. Knowledge of applicable regulatory requirements
  • Relevant Experience working in the pharmaceutical or Biotechnology Industry over a minimum of 5 years OR minimum of 2 years experience as a practising QP

If interested in this posting please feel free to contact Rachel Kent on +353 (0)87 427 8808 or [email protected] for further information.